Psilocybin Technology https://psilocybintechnology.com The latest in psilocybin technology Wed, 05 Feb 2020 18:14:41 +0000 en-US hourly 1 https://wordpress.org/?v=5.3.2 136717321 Patent Attorney Charles Boulakia joins Flourish Mushrooms https://psilocybintechnology.com/patent-attorney-charles-boulakia-joins-flourish-mushrooms/ https://psilocybintechnology.com/patent-attorney-charles-boulakia-joins-flourish-mushrooms/#comments Wed, 05 Feb 2020 18:09:19 +0000 https://psilocybintechnology.com/?p=4152 On February 4, 2020, the Yield Growth Corporation announced that Patent Lawyer, Charles Boulakia was appointed to the Flourish Mushroom Labs Advisory Board. According to the press release Mr. Boulakia ...

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On February 4, 2020, the Yield Growth Corporation announced that Patent Lawyer, Charles Boulakia was appointed to the Flourish Mushroom Labs Advisory Board. According to the press release Mr. Boulakia “has over 20 years of experience in the preparation and prosecution of patent applications in a variety of industries including: biotechnology, chemistry, biofuel, oil and gas and pharmaceuticals.”  Mr. Boulakia is a registered patent agent (reg. no. 58,616) at the United States Patent and Trademark Office. According to his firm’s webpage, Mr. Boulakia is a partner of Ridout & Maybee LLP in the firm’s Toronto office.

Yield Growth CEO, Penny White Discusses New Patent Attorney, Charles Boulakia

According to Yield Growth CEO, Penny White, “Our plan is to develop proprietary processes for the cultivation, extraction and processing of psilocybin magic mushrooms, and also develop data through trials about dosages and uses of psilocybin for therapeutic use.”  Towards these goals, Ms. White expressed her enthusiasm that “Charles [Boulakia’s] expertise will be an enormous asset as we develop our intellectual property strategy. He will also be instrumental in our efforts to scientifically prove certain therapeutic benefits of magic mushrooms.”

Yield Growth and Flourish Mushrooms Recent Patent Filing Efforts

On December 10, 2019, Yield Growth Corporation announced that its subsidiary Flourish Mushroom Labs filed a U.S. provisional patent application relating to “methods of using serotonin antagonists, in particular, psychedelic mushroom actives, for weight loss. See Yahoo Finance. See Psilocybin Technology’s article discussing how this work was originally considered groundbreaking.  Presumably, Mr. Boulakia will assist Flourish Mushrooms by developing this and other intellectual property assets.  From the press release, it also appear that Yield Growth and Flourish Mushrooms are in the process of developing an intellectual property strategy.

Based on the press release and other publicly available information , it is unclear how Mr. Boulakia will assist with “scientifically prov[ing] certain therapeutic benefits of magic mushrooms.”  Although Mr. Boulakia’s impressive academic record includes an M.Sc. (Biochemistry) from McGill University’s Cancer Research Centre (1996), his recent professional activity does not seem focused on conducting the clinical research required to “prove certain therapeutic benefits of magic mushrooms.”  Such scientific studies are typically conducted by medical doctors and research scientists.

Importance of Patents and Intellectual Property in Nascent Psychedelic Space

Despite a lack of clarity regarding the scope of Flourish Mushrooms’s IP portfolio or how Charles Boulakia will assist in  “scientifically prov[ing] certain therapeutic benefits of magic mushrooms,”  Yield Growth and Flourish Mushrooms are 100% clear about the importance of intellectual property within the nascent magic mushroom industry. See also Psychedelic Investment Opportunities.

Arguably, entrepreneurs looking to invest in psychedelics could generate the greatest returns by investing in research and development relevant to the future of the psychedelic industry.  Entrepreneurs could pursue patent protection for psilocybin technology and then leverage that advantage when the laws change.  E.g., decriminalization or legalization of magic mushrooms.  Following this logic, several entities, including Compass Pathways, Paul Stamets, CaaMTech, and Tassili Life Sciences have invested in intellectual property related to psychedelics.

 

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COMPASS Pathways’s Crystalline Form Patent https://psilocybintechnology.com/compass-pathwayss-crystalline-form-patent/ https://psilocybintechnology.com/compass-pathwayss-crystalline-form-patent/#comments Fri, 17 Jan 2020 20:09:37 +0000 https://psilocybintechnology.com/?p=3893 Recently, Compass Pathways issued a press release stating “that it has been granted US Patent No 10,519,175 (“the ‘175 patent”), relating to methods of treating drug-resistant depression with a psilocybin ...

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Recently, Compass Pathways issued a press release stating “that it has been granted US Patent No 10,519,175 (“the ‘175 patent”), relating to methods of treating drug-resistant depression with a psilocybin formulation, by the US Patent and Trademark Office.” According to COMPASS, “the patent covers the use of COMPASS’s synthesized investigational psilocybin formulation, COMP360, in a psilocybin therapy protocol for patients with treatment-resistant depression.” 

Given that psilocybin is an old drug, how did COMPASS get a patent covering its psilocybin product?

Answer: By recognizing that COMP360 is a novel crystalline form, COMPASS’s IP team at Cooley LLP was able to craft a patent strategy leading to the issuance of the ‘175 patent despite 60 years of prior art related to the compound psilocybin.  

Below we discuss the scope of COMPASS’s ‘175 patent and the clever IP strategy that led to the company’s success in acquiring that patent.

Claims of COMPASS’s US Patent No. 10,519,175

The ‘175 patent issued from COMPASS Pathways’s U.S. Patent Application No. 16/155,386 (“the ‘386 application”), which we discussed in a previous article.  During the prosecution of the ‘386 application, COMPASS amended the claims into the version which ultimately issued into the ‘175 patent.  The issued claims include a single independent claim (claim 1) and twenty dependent claims.  Claim 1 defines the the following subject matter:

“1. A method of treating drug resistant depression comprising orally administering to a subject in need thereof a therapeutically effective amount of an oral dosage form, wherein, the oral dosage form comprises:

crystalline psilocybin in the form Polymorph A characterized by peaks in an XRPD diffractogram at 11.5, 12.0, 14.5, 17.5, and 19.7°2θ±0.1°2θ, wherein the crystalline psilocybin has a chemical purity of greater than 97% by HPLC, and no single impurity of greater than 1%; and

silicified microcrystalline cellulose.”

Dependent claims 2 – 21 all require the elements recited in claim 1 in addition to the further limitations specified by each dependent claim.  Accordingly, all of the claims in the ‘175 patent require specific crystalline form attributes. In other words, all of the claims in COMPASS’s patent issued on account of incorporating the crystalline form data into the claims.

Patent Examiner’s Reason for Granting COMPASS’s Patent

The patent examiner at the USPTO explained the importance of its crystalline form data.  The examiner’s reason for allowing Compass’s claims was the difference between (A) the characteristics of the crystalline form of psilocybin recited in Compass’s claims and (B) the characteristics of the crystalline form of psilocybin recited in “the closest prior art of record, Folen.”  See Folen, V. A., X-ray powder diffraction data for some drugs, excipients, and adulterants in illicit samples. Journal of Forensic Science 1975, 20, 348-372.

 

The Genius of COMPASS Pathways’s Patent Strategy – Claiming Crystalline Forms

Psilocybin is an old compound.  Psilocybin has been known since at least 1958, when Hofmann isolated it from so-called “magic mushrooms.” Given that patents are only granted on “new” and “non-obvious” subject matter, acquiring a patent for COMPASS’s product, COMP360 was not an easy ask.  Nevertheless, COMPASS’s lawyers (Sandhya Deo of Cooley LLP) were able to pull a rabbit out of a hat in getting an allowance for U.S. Patent No. 10,519,175. 

Recognizing that psilocybin was a known compound, the IP team focused on the novel features of COMPASS’s product, COMP360.  That product apparently has new, non-obvious crystallographic features, which can be included in the definition of COMPASS’s invention, adding novelty despite all of the prior art related to psilocybin. 

Crystalline form patents often provide pharmaceutical companies with opportunities for acquiring patent exclusivity on drugs that have already existed in the prior art, such as psilocybin in the case of COMPASS’s product, COMP360. According to Barash Law,

“A solid-form patent strategy is even more important in drug repurposing where older chemical entities which either never made it to market or which were used in a different indication are being re-tasked. While new method of treatment patents may be available in such circumstances, more valuable composition of matter/drug substance patents should be considered when scientifically reasonable. Such strategies may involve creating new polymorphs, crystalline or amorphous salts or cocrystals to create a new composition of matter estate and Orange Book listing protections.”

In drafting the claims to crystalline form inventions, the applicant often relies on analytical data collected from x-ray diffraction experiments. “Because it can be difficult to characterize crystalline forms using organic chemistry nomenclature, one often relies on solid-state analytical data as a surrogate to define the metes and bounds of such claims.”  Such is the case with COMPASS’s claim strategy in US Patent No 10,519,175.  Although the claims are method claims (not composition of matter claims), COMPASS relied on solid-state analytical data to define the metes and bounds of those method claims: “…crystalline psilocybin in the form Polymorph A characterized by peaks in an XRPD diffractogram at 11.5, 12.0, 14.5, 17.5, and 19.7°2θ±0.1°2θ.”

Crystalline Form Patents for Psychedelics

COMPASS’s remarkable achievement in acquiring US Patent No 10,519,175 raises questions about other crystalline form patents.  Prior to COMPASS’s patent grant, many in the art considered “old” psychedelic compounds unpatentable by virtue of their being part of the public domain.  However, COMPASS’s success with psilocybin crystalline form patents suggests that other “old” compounds could be packaged into new, patentable inventions by leveraging opportunities created by x-ray crystallography.  Will crystalline form patents be the next gold rush for companies pursuing IP on previously known compounds?

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Psychedelic Investment Opportunities – 2020 Perspective https://psilocybintechnology.com/psychedelic-investment-opportunities-2020-perspective/ https://psilocybintechnology.com/psychedelic-investment-opportunities-2020-perspective/#comments Thu, 09 Jan 2020 00:07:43 +0000 https://psilocybintechnology.com/?p=3778 Investing in psychedelics (e.g., magic mushrooms, psilocybin, etc.) has became a hot topic during 2019.  Following Peter Thiel’s investment in Compass Pathway in 2018, several high-profile investors entered the psychedelic ...

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Investing in psychedelics (e.g., magic mushrooms, psilocybin, etc.) has became a hot topic during 2019.  Following Peter Thiel’s investment in Compass Pathway in 2018, several high-profile investors entered the psychedelic space during 2019. Tim Ferriss helped launch the world’s first research center (“Imperial Center for Psychedelic Research”) dedicated to turning psychedelics into medicines.  Shark Tank investor Kevin O’Leary joined former Canopy Growth CEO Bruce Linton by investing in the new psychedelic company MindMed.

Aside from high-profile investors, many new psychedelic entities emerged in 2019.  Entities working in the space have also illustrated an increased focus on intellectual property. Taken together, all of this activity demonstrates continued momentum towards developing a psychedelic industry.

Below, we have listed some key developments leading into 2020, which provide clues about the future of the psychedelic industry.

Big Opportunity for Investing in Psilocybin Technology

In 2019, we posed the question “Are magic mushrooms (or psilocybin) going to be the next big investment opportunity after cannabis?”  Now, considering developments from 2019, the answer appears to be “yes.” Former CEO of Canopy Bruce Linton succinctly explains this sentiment: “The therapeutic potential of psychedelics is greater than cannabinoids, for sure.” 

In view of the surge of available capital from investors and the rapid emergence of new business, one might ask where the greatest opportunities lie.  What research and development activities are pushing the state of the art forward? Here, it is interesting to note that most players in the space are conducting research and development almost exclusively on two types of products: (1) Single Active Ingredients, like psilocybin; and (2) Natural Organisms or extracts.

There has been almost no work done to develop products that include a full spectrum of active ingredients (found in natural organism or their extracts) with the chemical precision typically associated with a pharmaceutical product.  Experts in both chemistry and mycology have stressed the value of investigating the non-psilocybin components of magic mushrooms and harnessing the potential benefits of compositions comprising multiple active mushroom ingredients in a standardized form.  Although a few entities have hinted at this technology, most still appear to be focused on either pure single molecules (like psilocybin) or natural mushrooms.

Although many entities have started filing patents directed to psychedelics, the space is still relatively new and uncrowded.  As the space develops, the importance of good intellectual property will increase; and the likelihood of creating meaningful intellectual property will probably decrease.  Accordingly, investing in companies developing new, broadly applicable technologies with a strong commitment to intellectual property seems to be the best strategy as we enter 2020.

Pure Synthetic Psilocybin – Everyone’s Current Focus

Most research and innovation pertaining to psilocybin has focused on the therapeutical potential of synthetic psilocybin. In 2019, clinical trials run by King’s College London showed that patients taking 10mg and 25mg doses of pure psilocybin experienced no adverse side-effects. Compass Pathways has been developing pure psilocybin as a treatment for Treatment Resistant Depression (“TRD”); Usona has been developing pure psilocybin as a treatment for Major Depressive Disorder (“MDD”).

Progress in both scientific research and product development has raised concerns about access to psilocybin (e.g., pure psilocybin costs $7000-8000 per gram) and sparked conversations about less expensive bioequivalent alternatives like psilacetin.  Others have pursued alternative methods of making psilocybin, such as bioengineering. 

CB Therapeutics is addressing the need for supplying psilocybin and its analogs by genetically modifying yeast to make these compounds. According to their press release, CB Therapeutics has achieved the successful biosynthesis of psilocybin, psilocin and related tryptamine-based compounds typically found in plants and fungi.  Similarly, in 2019 scientists at Miami University of Ohio published the first example of psilocybin production in prokaryotic host.

Growing Recognition that Psilocybin is Only One of the Active Ingredients in Magic Mushrooms

Given the promising results for using psilocybin as a medicine, some chemists and mycologists have pointed out that psilocybin is only one of several active ingredients found in magic mushrooms. Through 2019, there was a growing appreciation that psilocybin is only one of many active molecules in “magic mushrooms.” Magic mushroom expert, Paul Stamets believes that psilocybin is just “the tip of the proverbial iceberg” in view of many unstudied psilocybin analogs or derivatives. See Stamets & Rogan Podcast #1385

The scientific community agrees that taking pure psilocybin is different from consuming “magic mushrooms” because mushrooms (or mushroom derived products) contain a cocktail of active ingredients instead of just one active molecule.  The naturally occurring combinations of active ingredients found in mushrooms unquestionably produce different clinical and pharmacological effects compared to pure psilocybin.  Expert mycologist Paul Stamets told Joe Rogan that the “wave of the future” will be harnessing the “entourage or symphony effect” that comes from combining multiple active ingredients from magic mushrooms in a “standardized form,” rather than myopically focussing on pure psilocybin or ignoring the variability incident to natural mushroom compositions. See Stamets & Rogan #1385, above. Entering 2020, there appears to be a substantial opportunity for developing standardized formulations that include combinations of multiple magic mushroom compounds.

Despite the recent attention for psilocybin therapies, our understanding of magic mushroom compositions is still in its early stages.  According to the American Chemical Society, even “the biosynthesis of psilocybin was a mystery” until 2017.  Aside from legal impediments to research, our poor understanding of magic mushrooms is due to an unmet need for chemical rigor within the magic mushroom space.  For example, prior to 2017, methods for characterizing the chemical composition of magic mushrooms were inherently flawed because those methods altered the chemical compositions under analysis and resulted in errors of +/- 300%. See Journal of Natural Products, 2017;80(10):2835-2838(“quantitative differences of the indole alkaloid profile were observed…”)(“Previous research showed that different [biomass] extraction methods heavily impact the [indole alkaloid] profile….”).  

Responding to these problems, Hoffmeister developed “a simple and artifact-free extraction method that … helps reflect the naturally occurring metabolic profile of Psilocybe mushrooms in subsequent analysis” in 2017.  Using these methods, Hoffmeister discovered norpsilocin in magic mushrooms in 2017.  In late 2019, Hoffmeister identified several β-Carboline monoamine oxidase inhibitors in magic mushrooms. Chem. Eur. J.. In late 2019, Hoffmeister identified several β-Carboline monoamine oxidase inhibitors in magic mushrooms. Chem. Eur. J..  When interviewed about the work, Dr. Hoffmeister highlighted the ongoing need to “study fungi from a chemistry perspective.” Chemistry World.  

Despite some progress studying magic mushrooms from a chemical perspective, the non-psilocybin components of magic mushrooms (aka psilocybin analogs or derivatives) remain largely ignored.  This lack of chemical understanding raises safety & efficacy problems for products derived from natural sources, like magic mushrooms because it prevents consistency in dosing and fails to account for unwanted side effects like temporary paralysis.  

Studying the non-psilocybin components of magic mushrooms presents an enormous opportunity for creating drug products superior to pure psilocybin. Drawing from the analogy to cannabis, the effects of full-spectrum products have proven far better and more diverse than single isolated compounds, like pure THC (aka Marinol).

Paul Stamets described the situation in late 2019: “The problem with natural products is how do you standardize them to the active constituent when you have more than one active constituent, you know, how do you standardize them all?” Stamets & Rogan #1385.  Bruce Linton of MindMed agrees: “What I want to know is what amount, in what way, to get what outcome?” As we enter 2020, scientists recognize that the ingredients in magic mushrooms offer advantages over pure synthetic psilocybin; but there is still an unmet need to make formulations with standard amounts of particular ingredients.

As we enter 2020, there appears to be an opportunity for chemotyping magic mushrooms, correlating clinical effects with chemotypes, and cultivating varieties that provide the most desirable properties.

Natural Psychedelic Products – Magic Mushrooms

Throughout 2019, there has been increasing support for the idea that people have the right to use natural medicines, especially if people have access to safe/standard doses of known ingredients. Denver became the first city to decriminalize magic mushrooms in May of 2019. Oakland and Chicago followed shortly thereafter. Now, almost 100 other cities are seeking decriminalization at some level. In 2020, California may vote to allow for the sale of magic mushroom derived products, including formulations. See “11395.120 Psilocybin Mushrooms.” See also here and here.

As discussed above, using magic mushrooms as a means for administering psilocybin and other active ingredients results in considerable ambiguity regarding the amount and chemical composition.  In 2019, several companies began work towards solving this problem.

In 2019, Silo Wellness developed a magic mushroom based nasal spray designed to administer standard doses of active ingredients.  According to Silo Wellness’s CEO Mike Hartman, “We addressed the age-old trouble with plant- and also fungus-based medicine: Exactly how do you understand just how much is a dose?” “The nasal spray being created is not pure psilocybin, but rather, Arnold tells New Atlas is a “full myco-spectrum extract of Jamaican magic mushrooms in an aqueous solution.”  Notably, Silo Wellness’s product recognizes limitations of pure psilocybin and need for “full spectrum” compositions in precise dosage forms. At this point it is unclear how Silo Wellness formulates its nasal spray to ensure consistency across batches of the product.  It is also unclear whether Silo Wellness simply uses full spectrum mushroom extracts; or whether their compositions are formulated with particular ratios of ingredients designed to optimize the polypharmacology of magic mushrooms. Notwithstanding Silo Wellness’s work, there appears to be an opportunity for creating formulations that include optimized combinations of psilocybin analogs and also exhibit little or no variability between batches.  

In 2019, Field Trip Ventures announced “the world’s first legal research and cultivation facility for psilocybin-producing mushrooms.”   According to their President, Mujeeb Jafferi, “One of the goals is to build a library of psychoactive fungi and developing scalable commercialization options.”  He explains, “We know of a few alkaloids based in these mushrooms but there’s a lot we don’t know yet.”  According to Bloomberg, “Field Trip’s Jafferi believes the Jamaican research lab could provide a better understanding of how some of the 180-odd mushrooms known to contain mind-altering molecules work as it aims to enter them into clinical trials.”

Another new company, OLP Therapeutics appears to recognize the importance of both consistency and full spectrum mushroom products.  OLP’s stated vision is “Creating standardized, pharmaceutical-grade, natural mushroom products.” They explain, “Critical to our work is chromatography that allows for analysis and labeling of percentages of active ingredients,” including “maintaining strict standardization of psilocybin products.”

Another relatively new company, Orthogonal Thinker has announced a psilocybin product called Psilly.  The company explains that “Psilly differs from other psilocybin products in development as it consists of a proprietary formulation that uses natural, rather than biosynthetic, alkaloids.”  Like Silo Wellness’s product, Psilly appears to utilize naturally produced ingredients rather than synthetic compounds; and it is unclear how Orthogonal addresses consistency and precision in the dosage formulations.  Presumably a “proprietary formulation” would include a deliberately chosen collection of active ingredients; but it is unclear whether Psilly was formulated based on any polypharmacology data. 

Another new company, Frontier Neurochem describes itself as “a global life sciences focusing on researching, developing and commercializing novel therapeutics based on serotonergic 5-HT2a agonists including previously overlooked psychedelic compounds for the emerging field of Psychedelic Medicine.”  The company has also developed a storefront for selling psilocybin analogs.

Also established in 2019, ThinkMyco, a mycology and mushroom-derived product company focuses on “discovering and commercializing fungal derived bio-pharmaceuticals” by “developing next-generation bio-pharmaceuticals and unique delivery systems by studying naturally occurring neurogenic fungal compounds for the treatment of central nervous system indications.”

Despite the growing support for increasing access to magic mushrooms and other natural sources of psychedelic drugs, we still have a poor understanding of the chemical composition of mushrooms. But, there is an increased recognition of the problems created by a general lack of chemical precision with natural psychedelics, like magic mushrooms.  In 2019, several companies entered the space with the goal of developing standardized formulations that include precise amounts of ingredients, where the ingredients are selected to harness the entourage effect.

New Psychedelic Compounds

In 2019, the Cheong group at the Uimyung Research Institute for Neuroscience at Sahmyook University designed and synthesized four novel synthetic tryptamine analogs and demonstrated their activity at the serotonin-2a receptor.

In 2019, CaaMTech scientists published work describing the chemical synthesis and characterization of several synthetic psilocybin derivatives.

Intellectual Property – Psychedelic Patent Filings Increase

In a previous post on Psychedelic Investments, we pointed out that Intellectual Property would become a key consideration within the nascent psychedelic industry. In mid 2019, we noted that a few early movers, including Compass Pathways, Paul Stamets, CaaMTech, and Tassili Life Sciences had invested in intellectual property related to psychedelics.  Now, about 6 months later, the race to patent psychedelic inventions is fully underway.

CB Therapeutics has filed a patent for its production process, which appears to be biosynthesis using genetically modified yeast and a continuous extraction process. According to Sher Butt, CEO of CB Therapeutics, “Our team of talented scientists and engineers are dedicated to developing new methods and systems to advance synthetic genomics and bio-engineering….This has resulted in a rapidly growing IP portfolio as we continue to file patent applications…”. Press Release November 14, 2019.

In July of 2019, Silo Wellness filed a provisional patent application intended “to cover metered dosing formulations of plant and fungal compounds for oral, nasal, sublingual, and topical use.metered dosing.”  See Silo Wellness Patent Application.

Kevin O’Leary and Bruce Linton backed “MindMed is building an IP portfolio and undertaking clinical trials of medicines based on psychedelics. MindMed will also grow its pipeline through acquisitions, Joint-Ventures, and collaborative development agreements.”

Tassili Life Sciences, Corp. has four patents pending, all with 2019 priority dates.  Tassili appears to be focussed on IP and the company has a section of their webpage dedicated to Intellectual Property.

According to Google Patents, CaaMTech has filed multiple worldwide patent applications directed to psilocybin derivatives, combinations thereof, and methods of treating a variety of conditions.

Compass Pathways has filed patent applications for GMP psilocybin and a specific crystalline form of psilocybin. See also statement from Ekaterina Malievskaia (founder of COMPASS) about Compass’s IP. According to Bloomberg, Compass’s co-founder George “Goldsmith says the cost of the clinical trials forced him and Malievskaia to go for-profit, to protect their specific techniques as intellectual property and give potential investors the confidence to write checks.” Notably, Rick Doblin, the nonprofit psychedelics advocate, says “Compass’s patent applications are narrow enough that they won’t threaten a nonprofit effort in the U.S..”

Yield Growth Corp. and its subsidiary Flourish Mushroom Labs “has filed 13 patents to protect its extraction method and formulas and one patent for the use of compounds in psychedelic mushrooms to treat obesity and diabetes and to aid in weight loss.” See Yahoo Finance. According to their press release on Bloomberg, “Yield Growth earns revenue through multiple streams including licensing, services and product sales.”

According to their press releases, Orthogonal Thinker “has raised approximately over $5 million in total seed capital, with some of the proceeds being used to further develop and pursue intellectual property protection on Psilly, the Company’s proprietary psilocybin product, according to the letter of the law.” The company boasts an “Approximate $90 Million Valuation.” (“Plant Science and Product Development Company Raises Additional Funds to Further Psychoactive Intellectual Property Development.”)

According to their webpage, Frontier Neurochem “has developed patent-pending technologies and formulations of Psilocybe mushroom and Iboga alkaloids extracts meeting cGMP Pharma-grade standards for safe and effective pharmaceuticals.”

ThinkMyco describes its business focus as the “development of unique technologies and IP spanning the whole range of fungi based growth industries.”

Future of Psychedelic Industry

In 2019, investors began to enter the psychedelic space and companies increased their focus on intellectual property.  This momentum grew throughout 2019 and promises to build into 2020. Against that background, investors and scientists agree that there is still an unmet need for fundamental scientific research.  Despite the promising results, we still don’t understand the chemical composition of naturally occurring psychedelics or how variations in that composition correlate with clinical properties.  These unmet needs create opportunities for entering (or investing in) the space in 2020.

Given technological landscape and the state of the art, the future of the psychedelic industry will require rigorously characterizing natural sources of psychedelic drugs and correlating their variable clinical effects with chemical composition. This work will support the development of next generation psychedelic formulations that provide improved properties (compared to single active ingredients) in standardized dosage forms.

Based on the above, in 2020 one might expect investors to seek out companies that are developing (and patenting) technology that supports the development of standardized psychedelic formulations that have multiple active ingredients in reliable dosage forms.

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Compass Pathways Discusses Psilocybin Patents https://psilocybintechnology.com/compass-pathways-discusses-psilocybin-patents/ https://psilocybintechnology.com/compass-pathways-discusses-psilocybin-patents/#comments Thu, 19 Dec 2019 00:07:35 +0000 https://psilocybintechnology.com/?p=3524 Ekaterina Malievskaia, co-founder of Compass Pathways recently published a statement about the company’s psilocybin research program, including a section about “MANUFACTURING AND PATENTING” psilocybin. See MAPS website.  The statement appears ...

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Ekaterina Malievskaia, co-founder of Compass Pathways recently published a statement about the company’s psilocybin research program, including a section about “MANUFACTURING AND PATENTING” psilocybin. See MAPS website.  The statement appears to respond to the Statement on Open Science signed by many leaders in psychedelic research.  Recently, the U.S. Patent and Trademark Office granted COMPASS Pathways U.S. Patent No. 10,519,175, which covers methods of treating treatment resistant depression with a specific crystalline form of psilocybin.

In the statement Ms. Malievskaia explains that making an Investigational Medicinal Product (an “IMP”) is difficult and expensive and that sharing the product of that work could only be accomplished through standard licensing agreements, which protect Compass’s ability to “recoup the expenses” and “ensure the integrity of the data collected” by controlling who has access to psilocybin made through Compass’s manufacturing patents. 

Ms. Malievskaia notes that Compass’s intellectual property does not prevent members of the community from inventing different psilocybin manufacturing procedures, using other sources of the psilocybin, or buying Compass’s product. In other words, others will be excluded from using Compass’s (arguably better) manufacturing process unless they enter into some form of licensing agreement with Compass. The good news is that Compass will not have a monopoly on magic mushrooms as some journalists have contended.  

Below, the “MANUFACTURING AND PATENTING” section of Compass’s statement is reproduced with emphasis on several relevant portions used to synthesize the above summary.  

Statement from Compass (boldface added):

While psilocybin is a naturally occurring molecule, psilocybin as an Investigational Medicinal Product or IMP is a regulatory entity that includes a detailed description of a GMP-compliant, scalable and reproducible manufacturing process; associated preclinical data; and ongoing safety data collected in clinical trials. The IMP can be thought of as a product’s fingerprint, so that regulators can recognize the safety and efficacy evidence gathered in the clinical trials as it relates to this unique product. The creation of an IMP is an extremely complex and expensive process that requires sustainable funding and a serious multi-disciplinary team effort. Based on our experience and the regulatory input from EMA, we now estimate that the development process will continue through marketing authorization and cost over £3 million (nearly $4 million).

In the process of synthesis, formulation and creation of preclinical data, we reached out to the researchers at Heffter and Usona with offers to share experience and ever rising cost, the last conversation being at PS17 in Oakland. Shortly after, the initial phases of the synthesis and formulation were completed, and psilocybin became the Investigational Medicinal Product. From that point on, for the reasons of data consistency, there was no regulatory acceptable mechanism of “sharing” it other than through standard licensing agreements for the use of IMP. This is the way clinical research regulation works around the world.

As the previously published synthesis processes did not scale to meet regulatory standards, we had to invent our own process. As he would have done for anyone who would have asked for his help, David Nichols advised our manufacturing team. With his support our team has solved over 60 distinct technical problems in the synthesis and formulation process. Some of these inventions became the basis for our manufacturing patents. In general, patents provide an opportunity for an organization willing not only to take a significant financial risk to recoup the expenses, but more importantly, to ensure integrity of the data collected before and after the approval.

Our patents do not preclude others from creating a range of different solutions for the synthesis and formulation of psilocybin; nor do they preclude the use of naturally occurring mushrooms, extracts, or any other products created by alternative synthesis and formulation routes. Equally, our patents do not prevent other clinicians from using our product or any psilocybin-containing products in conjunction with the types of therapy or psychological support they judge to be helpful, as long as it does not jeopardize patient safety. Lastly, neither our patents, regulatory strategy, nor pricing strategy have an impact on the practices of the underground community of practitioners in nonclinical settings.

Our exclusive contract with the drug manufacturer does not prevent others from choosing among many different competing manufacturers through the standard Request for Proposal (RFP) process. The advances of science may now offer new creative solutions for the synthesis and formulation of psilocybin with new partners for those who are willing and able to spend the time, effort, and funds to create an alternative psilocybin-based IMP.

While we have created the supply of psilocybin for our own research, we have made the unusual decision to share it with qualified independent researchers free of charge in exchange for being able to use their safety data. [Is something really “free” if the receiving party must provide valuable date “in exchange” for it?] This is not a commercial decision, but yet another way to accelerate the generation of clinically relevant evidence that may ultimately improve patient outcomes.

This process has proven to be challenging at times. As we have learned, university legal departments and technology transfer offices are vigilant about the potential Intellectual Property (IP) that might be created in the process of investigator-initiated studies. This IP, despite the best intentions of the researchers, does not belong to the scientists, who have limited say in how it is used by their institutions. In the event of IP creation, Technology Transfer Offices have a legal obligation to license it out to the ‘highest bidder’ with the most aggressive and scalable business model that will generate the most return for the academic institution. Even though such IP would be created by independent researchers with our IMP, in order to use the invention, we still have to compete with other commercial entities who might have different ethics or commercial goals.

This is an important consideration for the signatories of the Statement on Open Science and Open Praxis who work for academic institutions, as they need to align with their institutions on terms of IP licensing. The core principle of the statement is that knowledge created by signatories is open to all – that is, the knowledge is to be given away unconditionally by relinquishing researchers’ rights to protect it and to control who gets to use it after it becomes public.

We believe our patent strategy offers some protection against uses that may not be fully aligned with our mission to create access to innovative treatments for as many people as possible at an affordable cost to patients and health care systems.

 

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Has Yield Growth subsidiary Flourish Mushroom Labs revolutionized the field of psychedelics? https://psilocybintechnology.com/has-yield-growth-subsidiary-flourish-mushroom-labs-revolutionized-the-field-of-psychedelics/ https://psilocybintechnology.com/has-yield-growth-subsidiary-flourish-mushroom-labs-revolutionized-the-field-of-psychedelics/#comments Tue, 10 Dec 2019 17:14:57 +0000 https://psilocybintechnology.com/?p=3482 Yield Growth subsidiary Flourish Mushroom Labs appears to have discovered a fundamentally new use for the active compounds in magic mushrooms, i.e. psilocin and its prodrug psilocybin. On December 10, ...

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Yield Growth subsidiary Flourish Mushroom Labs appears to have discovered a fundamentally new use for the active compounds in magic mushrooms, i.e. psilocin and its prodrug psilocybin.

On December 10, 2019, Yield Growth Corporation announced that its subsidiary Flourish Mushroom Labs filed a U.S. provisional patent application relating to “methods of using serotonin antagonists, in particular, psychedelic mushroom actives, for weight loss. See Yahoo Finance (emphasis added).

This development is exciting for at least two reasons:

  1. Using active compounds from magic mushrooms as serotonin-2a (i.e., 5HT-2a antagonists) represents an entire new area in psychedelic research.
  2. This departure from the accepted knowledge about psilocybin/psilocin suggests that Flourish Mushroom’s new use of these compounds as 5HT-2a antagonists will likely result in patentable subject matter.  (Inventions that represent a major departure from accepted knowledge are usually considered “non-obvious” during examination at the patent office.)

According to the press release, the Flourish Mushroom Labs patent application pertains to administering psilocin and/or psilocybin to provide an overall weight loss in individuals.  The weight loss is achieved by reducing food cravings, counteracting compulsive overeating, and aiding in improving quality of diet by altering food choices. The application also attempts to claim methods of administering “microdoses” of psilocin/psilocybin to provide weight loss by “increasing metabolism, which, combined with a decrease in food cravings or compulsive overeating, or altering food choices to less calorie dense foods, could result in substantial and beneficial weight loss.” Yield Growth also claims that “the Flourish Mushroom Labs pending patent also covers the use of psilocin/psilocybin in treatment or regulation of diabetes, and regulation of blood glucose and to reduce susceptibility to cardiovascular disease, high blood pressure, diabetes mellitus and other illnesses associated with obesity.”

Yield Growth’s New Approach to Psychedelics as Serotonin Receptor Antagonists.

According to Yield Growth’s press release about Flourish Mushroom Labs Provisional Patent Application, “Psilocin/psilocybin is known as 5-HT2A agonists or partial agonists.”

Psilocin is a known 5HT-2A agonist.  Psilocybin is recognized as an inactive prodrug of psilocin, i.e., neither an agonist or an antagonist.

Yield Growth’s description of Flourish Mushroom’s patent application is as follows: “U.S. PATENT TO USE SEROTONIN ANTAGONISTS FROM PSYCHEDELIC MUSHROOMS FOR WEIGHT LOSS.”

Although neither Yield Growth’s website nor the press release provides detailed information about the technology, the use fo psilocybin/psilocin as a 5HT-2A antagonist represents a significant departure from previous approaches.  To date, all other research has focused on using psilocybin as a prodrug of psilocin, thereby providing psilocin as a 5HT-2A agonist with an increasing number of applications.

This development highlights the tremendous opportunities for making new fundamental breakthroughs in the space.  It will be fascinating to follow Yield Growth and Flourish Mushrooms as they develop this new technology, which seems to defy accepted wisdom about psilocin’s method of action.

 

 

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Patent Pending Psilocybin Formulation from Silo Wellness https://psilocybintechnology.com/patent-pending-psilocybin-formulation-from-silo-wellness/ https://psilocybintechnology.com/patent-pending-psilocybin-formulation-from-silo-wellness/#comments Wed, 04 Dec 2019 23:12:25 +0000 https://psilocybintechnology.com/?p=3454 Silo Wellness just announced the world’s first metered-dose magic mushroom nasal spray. The nasal spray formulation was designed to provide users with rapidly absorbed and predictable doses of “full spectrum” ...

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Silo Wellness just announced the world’s first metered-dose magic mushroom nasal spray. The nasal spray formulation was designed to provide users with rapidly absorbed and predictable doses of “full spectrum” magic mushroom compositions.  According to Silo Wellness founder, Mike Arnold, the new formulations were made to address an unmet need for precision dosing: “This is a business problem in need of a solution.  I reached out to my long-time colleague from the marijuana space, brilliant inventor Michael Hartman, and we agreed that we need to be able to give patients predictable dosing so they can self-titrate into the desired levels of sub-psychedelic or psychedelic treatment.”  

The inherent chemical variability of naturally occurring magic mushrooms has been a longstanding unmet need for people wishing to consume precise and reliable amounts of full spectrum psilocybin composition.  See State of the Art for Microdosing Psychedelics. To date, the existing options have been either (a) consume mushroom fruiting bodies or (b) consume a single purified chemical. The former fails to provide precise or reliable doses of known ingredients; the latter fails to provide the synergistic benefits of full spectrum mushroom compositions.  See Entourage Effect.  We have previously pointed out that the future of the magic mushroom industry will be formulated tryptamines.  Paul Stamets recently expressed a similar view regarding the benefits of “standardized” doses on the Joe Rogan Podcast #1385.

Silo Wellness’s Patent Strategy

Silo Wellness is also clear about its aggressive intellectual property strategy, which has become in important consideration for investors in the psychedelic space.  Silo Wellness’s webpage emphasizes its “Provisional Application for a Patent for metered dosing formulations” and directs readers to an entire page dedicated to Intellectual Property.  On its intellectual property page, Silo Wellness explains: “We have filed [in July 2019] a provisional application for a patent to cover metered dosing formulations of plant and fungal compounds for oral, nasal, sublingual, and topical use. We are developing solutions for metered dosing for mushrooms, Ayahuasca/DMT, and peyote/mescaline.”  The intellectual property was apparently developed by Michael Hartman, who has developed extensive metered-dose inhaler IP for other pharmaceutical companies. Examples of Mr. Hartman’s metered dose technology can be found here and here.

Silo Wellness further highlights it’s IP-guided strategy by describing its dual focus on technology and IP:  “The problems we are attempting to address through protectible IP (patent and trade secrets) are as follows: 1. How to deliver a predictable and safe experience; and 2. How to make them palatable.

Foreshadowing a Patent Licensing Strategy?

According to their webpage, Silo Wellness “intend[s] to be directly involved through ownership interests, product licensing agreements, and management contracts in the cultivation, manufacturing, and therapy dosing in this emerging space.”  Silo Wellness’s description of their Nasal Spray formulation also includes a section about “Licensing the Technology for Manufacturing,” where the company invites discussions about licensing their IP.

“If you have a lab in Jamaica or are otherwise interested in licensing our technology in advance of legalization in your home jurisdiction, please contact our team for available territories.”

Although Silo Wellness frequently mentions its intellectual property and licensing strategy, there is no information about the scope or contents of its patent portfolio.  The webpage states that their provisional patent application was filed in July of 2019, suggesting that the content of that patent disclosure will not publish until about January of 2021 (18 months from the earliest priority). Presumably, the IP is centered around “metered dosing formulations,” leveraging Mr. Hartman’s expertise with metered dose inhalers.  However, it is not clear what chemical compositions will be used in the metered dose inhalers or whether those compositions are subject to patent protection by Silo Wellness or another entity, like Paul Stamets who holds multiple earlier-filed patent applications on magic mushroom compositions.

Conclusions – The Patent Race has Begun

On August 28, 2018, the Waking Times published an article explaining that “The Race to Patent Magic Mushrooms Heats Up.”  Since that time, there have been murmurings about different entities filing patent applications on magic mushroom formulations or related technology.  But, with their heavy emphasis on patent strategy, Silo Wellness has confirmed earlier suspicions that the patent race has begun in the psychedelics industry.  Here, Mike Arnold refers to the “Shroom Boom” as the “New Cannabis Green Rush,” adding that the peer-reviewed studies are even stronger.  However, Mr. Arnold further notes: “When everyone is running in one direction, that’s the last place an entrepreneur or investor wants to be. If you were on time for cannabis, you were already too late.”  Given that patents are awarded to the first inventor to file, do these signs of the psychedelic patent race indicate that it’s already too late to make a meaningful IP play in the space?

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American Chemical Society Meeting – Only One Talk about Psychedelics? https://psilocybintechnology.com/american-chemical-society-meeting-only-one-talk-about-psychedelics/ https://psilocybintechnology.com/american-chemical-society-meeting-only-one-talk-about-psychedelics/#comments Sun, 18 Aug 2019 18:11:26 +0000 https://psilocybintechnology.com/?p=2513 The upcoming 2019 American Chemical Society (“ACS”) Fall Meeting and Exposition in San Diego features two presentations pertaining to psychedelic chemistry: (1) a talk by Dr. David Manke and Dr. ...

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The upcoming 2019 American Chemical Society (“ACS”) Fall Meeting and Exposition in San Diego features two presentations pertaining to psychedelic chemistry: (1) a talk by Dr. David Manke and Dr. Andrew Chadeayne, about the chemistry of psilacetin; and (2) a poster presentation by Sm Ashikur Rahman on the synthesis of several psychedelic molecules.  The enormous potential for psychedelic drugs combined with significant gaps in our chemical understanding of these substances suggests that the topic is underrepresented at the upcoming ACS conference.

Psychedelic Drugs – an Important Chemical Topic

Psychedelic drugs have recently attracted attention as potential treatments for many of the world’s most costly health problems. Over the past several years, the scientific community has been outspoken about the therapeutic potential for drugs like psilocybin, LSD, ketamine, DMT, 5-MeO-DMT, ibogaine, MDMA, and others.  See, e.g., Johns Hopkins study. However, despite the enormous global importance of these drugs, they have received almost no attention from the chemical community. This omission seems especially important given the following challenges facing the psychedelic community:

  • Highly variable chemical composition of naturally derived psychedelics;
  • Unknown and potentially dangerous chemicals in naturally derived psychedelics;
  • Variability in chemical concentration of naturally derived psychedelics;
  • Unreliable purity and physical characterization of existing psychedelic drugs.

The above described gaps in chemical understanding prevent progress in other areas of scientific research.  For example, the medical community cannot draw valid conclusions about the effect of naturally derived psychedelics (e.g., magic mushrooms) without knowing the chemical composition of those substances.  In the case of “magic mushrooms,” both the chemical profile (ratio of psilocybin derivatives) and total concentration thereof vary substantially. Those variations are known to cause significant differences in the clinical effect.  

Unmet needs in chemical research not only impeded research in applied sciences like biology.  Lack of chemical understanding also creates significant barriers to legal and political progress.   For example the “Decriminalize Nature” organization seeks to unwind legal deterrents to possessing and using natural psychedelics, like magic mushrooms. The group, led by Kevin Mathews has succeeded in decriminalizing magic mushrooms in Denver. Similar efforts have succeeded in Oakland. As a result, other efforts are taking hold across the United States.  Unfortunately, this legal and political progress has surpassed our chemical understanding of the natural products at issue. For example, some of the language is unclear about the scope of the chemicals at issue — are these groups decriminalizing magic mushrooms or do they intend to include purified molecules from those mushrooms– or synthetic derivatives thereof?  Additionally, developing a chemical understanding is important because magic mushrooms are highly variable in their chemical composition and some species have (unknown) chemicals that cause paralysis, i.e., “Wood Lover Paralysis.”

Psychedelic Presentations at the American Chemical Society

The American Chemical Society (“ACS”) is the world’s largest scientific society. The American Chemical Society’s mission is “to advance the broader chemistry enterprise and its practitioners for the benefit of Earth and its people” and  “to improve people’s lives through the transforming power of chemistry.” The upcoming 2019 Fall Meeting and Exposition in San Diego will feature two presentations (only one talk) pertaining to psychedelics. Information about these presentations is provided below.  Given the global importance and chemical nature (drugs are chemicals after all) of psychedelic drugs, the topic appears to be underrepresented at the American Chemical Society.

Psychedelic Chemistry Presentation #1 – Dr. David Manke and Dr. Andrew Chadeayne

David R Manke from the Department of Chemistry & Biochemistry, University of Massachusetts Dartmouth and Andrew R Chadeayne of CaaMTech, LLC will present on the “Chemistry of Psilacetin: Prodrug of psilocin.”  According to UMass Dartmouth’s webpage, Dr. Manke is an Associate Professor of Chemistry & Biochemistry.  According to LinkedIn, Dr. Chadeayne is Founder and Inventor at CaaMTech, LLC, former Chief Innovations Officer at Ebbu, and a former patent practitioner.

The abstract of their presentation to the American Chemical Society is as follows:

“Psychedelic drugs have earned newfound attention as treatments for some of society’s most troubling medical problems – depression, anxiety, addiction and PTSD. The tryptamines found in so-called “magic mushrooms” (e.g. psilocybin, psilocin, etc.) are particularly attractive because they appear to offer immediate and long-lasting benefits without unwanted side-effects. This great promise has led political groups across the United States to seek legislative reform for ‘magic mushrooms’.

Despite their potential benefits, the physical properties of these molecules have not been adequately studied. In this talk, we will present new developments regarding the purification, characterization, stability and chemical reactivity of psilocybin derivatives, including the first reported crystal structure of psilacetin fumarate, a readily attainable, cost-effective prodrug of psilocin.”

The work will be presented in a 30 minute presentation on Monday, August 26th at 10:20 am in Room 32B of the San Diego Convention Center,

Psychedelic Chemistry Presentation #2 – Mr. Ashikur Rahman

Sm Ashikur Rahman is a PhD Student in the Department of Chemistry at Western Virginia University. He will present on the “Total Synthesis of Complex Molecules.”  According to the West Virginia University Department of Chemistry webpage, Ashikur Rahman was awarded the 2017-18. Eugene Bennett Fellowship.

The abstract of his talk at the American Chemical Society is as follows:

“Ergot alkaloids have been shown to exhibit useful medicinal properties such as labor inducing activity, migraine relief, mood-perception regulation. Ergotryptamine, an ergot alkaloid, was recently isolated in minute amount from Aspergillus nidulans. In order to facilitate biological studies, this compound was selected as a target for synthesis. Proposed key synthetic steps include a palladium catalyzed Kosugi-Migita-Stille cross coupling, a Mizoroki-Heck reaction, and a carbon monoxide-mediated palladium-catalyzed reductive N-heterocyclization. Using a similar synthetic approach, synthesis of two indoles norpsilocin and aurantioclavine has been envisioned in 1-2 additional steps. Norpsilocin, a component of magic mushroom with promising psychotropic effects, was recently isolated from Psilocybe cubensis. Aurantioclavine was first isolated in 1981 from the fungus Penicillium aurantiovirens. It has become an attractive target for synthesis due to its role as a biosynthetic precursor to the communesin alkaloids, which display cytotoxicity against leukemia cell lines.”

The work will be presented on Wednesday August 28th at 7 pm in Exhibit Hall A of the San Diego Convention Center.

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Coffee with Psilocybin? https://psilocybintechnology.com/magic-mushrooms-in-morning-coffee/ https://psilocybintechnology.com/magic-mushrooms-in-morning-coffee/#comments Fri, 02 Aug 2019 21:00:23 +0000 https://psilocybintechnology.com/?p=2398 Based on newfound benefits of magic mushrooms and the changing cultural (and legal) climate, some early movers have started working on psilocybin containing consumer products, like foods and beverages. On ...

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Based on newfound benefits of magic mushrooms and the changing cultural (and legal) climate, some early movers have started working on psilocybin containing consumer products, like foods and beverages.

On July 29, 2019, Strava Craft Coffee announced its plans for introducing coffees and teas that include microdoses of psilocybin from magic mushrooms.  See New Atlas article by Rich Haridy.

Strava already produces “a Full-Spectrum CBD-Rich Hemp Infused Coffee line called “Peace & Wellness.”  According to Strava’s CEO, Andrew Aamot, moving into the magic mushroom space fits the company’s mission: “the company’s vision is to bring consumers amazing beverages infused with promising natural compounds.”
Mr. Aamot further explains that Strava’s goal “in the case of psilocybin, [is] to seek physical, mental and spiritual therapeutic benefits without triggering psychedelic “trips,” which can occur when psilocybin is consumed in high doses.”

“Strava doesn’t anticipate selling the beverages until 2020 at the earliest, banking on a more favorable regulatory environment emerging within the new few years.”

Strava CEO Andrew Aamot says in a statement announcing the new product: “As research is proving, with measured consumption, cannabis and psilocybin can both promote physiological, mental and spiritual health.”

According to their press release, Strava plans on infusing coffee and tea with “microdoses of psilocybin.” Stave’s statements also make clear that they intend to us“psilocybin from mushrooms,” aka “magic mushrooms,” as opposed to synthetic psilocybin.

Strava already has some experience making with naturally derived products. Strava was one of the first coffee roasters to sell CBD-infused coffee in 2017. 

Other logical fits for making psilocybin containing coffee include Four Sigmatic and Bulletproof.   Four Sigmatic is a “functional mushroom company,” which makes a line of mushroom based beverage formulations. Although Four Sigmatic has not made any formal announcements about making psilocybin containing products, its founder, Tero Isokauppila has discussed possibilities in the space.  See Maxim Oct. 14, 2018.

Bulletproof makes a line of “science-based” products. Bulletproof’s founder and CEO, Dave Asprey describes himself as the “Father of Biohacking,” which speaks to the companies mission: “take control of your own biology.”  Clearly psychedelics, like magic mushrooms have potential within the context of biohacking.  Nevertheless, Mr. Asprey explains in his blog that he has no intentions of including mushrooms in their coffee products. “In the early days of Bulletproof, we experimented with developing mushrooms and herbs to put in coffee. We put the kibosh on that for a few reasons, the main one being that mushrooms in coffee tastes like crap. Why ruin a perfectly good cup of coffee with the taste of mushrooms? Some types of mushrooms can be pretty earthy — that’s a coffee snob’s way of saying it tastes like dirt.”  Mr. Asprey appears to agree with the potential biohacking benefits of magic mushrooms by opposes the idea of including mushrooms in coffee: “With a little research, expert guidance, and self-experimentation, mushrooms can be a valuable addition to your supplement stack, without making your coffee taste mega gross.”

The Future of Psychedelic Beverages

On account of their newly appreciated health benefits and safety profile, magic mushrooms could become the next cannabis.  See Cannabis and Magic Mushrooms – a Near Perfect Analogy.  Such development will necessarily give rise to a variety of consumer products that provide users with options aside from eating mushroom fruiting bodies.  Beverages, like coffee and tea, are one logical product category.  But, it remains to be seen whether companies like Strava can develop products that don’t “taste like crap.”

Another lingering question is how manufacturers will control the does and chemical composition of the active ingredients.  Presently available cannabis coffees, like Strava’s “Peace & Wellness” line clearly articulate the precise amount of CBD contained in each serving.  Given the substantial chemical variability in magic mushrooms, any company using them within a formulation will need to control for both the different active ingredients in the mushrooms and the concentration of those ingredients. (Simply adding magic mushrooms to coffee or tea would result in considerable variability in both the identity and quantity of active psilocybin derivatives.). Arguably, the future of magic mushroom coffee and tea will adopt the precise and reliable dosing practices now standard in cannabis products.  This could be accomplished by using magic mushroom formulations having precisely dosed amounts of select ingredients.

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Psilocybin for Sale in Canada – Dana Larsen of the Medicinal Mushroom Dispensary https://psilocybintechnology.com/psilocybin-for-sale-in-canada-dana-larsen-of-the-medicinal-mushroom-dispensary/ https://psilocybintechnology.com/psilocybin-for-sale-in-canada-dana-larsen-of-the-medicinal-mushroom-dispensary/#respond Tue, 30 Jul 2019 18:43:48 +0000 https://psilocybintechnology.com/?p=2372 A recent article in Yahoo Finance reported that Dana Larsen of the Medicinal Mushroom Dispensary is selling psilocybin containing products. As discussed below, it is unclear whether these are mushrooms ...

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A recent article in Yahoo Finance reported that Dana Larsen of the Medicinal Mushroom Dispensary is selling psilocybin containing products. As discussed below, it is unclear whether these are mushrooms or some other form of psilocybin product.

Despite the current legal status of psilocybin (and magic mushrooms) Dana Larsen is selling psilocybin containing products online. He explains that his actives are limited to providing subthreshold doses to people with a medical need: “I’m only selling microdoses to people with a confirmed medical need.”

Is Dana Larsen Selling Magic Mushrooms or Psilocybin?

In the article, Elianna Lev of Yahoo Canada News uses the terms “psilocybin” and “magic mushrooms” interchangeably, which makes it unclear whether Dana Larsen is selling psilocybin (the single active molecule) or magic mushrooms (comprising psilocybin along with multiple other active ingredients). See Taking Pure Psilocybin is Different from Eating Magic Mushrooms.

At some points in the article, Ms. Lev appears to clearly distinguish magic mushrooms from psilocybin:

  • “Dana Larsen is behind the Medicinal Mushroom Dispensary, an online shop that sells microdoses of psilocybin, the psychoactive component in magic mushrooms.” 
  • “While magic mushrooms are illegal in Canada, psilocybin is being studied for its potential to treat mental illnesses like anxiety, depression, and PTSD, amongst others.”
  • These quotes suggest that Mr. Larsen is selling psilocybin (the chemical) not mushroom material containing it.
  • In the U.S., Denver and Oakland have decriminalized magic mushrooms. In Canada, there’s currently no therapeutic products containing psilocybin that have been approved.
  • “Larsen says some activists will be in court later this year to challenge psilocybin prohibition under Section 56 of the controlled drug act,”

However other parts of the article suggest exactly the opposite, that Mr. Larsen is selling small doses of magic mushroom material:

  • “Now that Canadians have access to legalized cannabis, a Vancouver-based activist is focused on administering another substance that’s said to have both medicinal and recreational benefits: magic mushrooms.”
  • While magic mushrooms are illegal in Canada, psilocybin is being studied for its potential to treat mental illnesses like anxiety, depression, and PTSD, amongst others.”
  • Notably, Mr. Larsen’s shop is called the “Medicinal Mushroom Dispensary.”
  • The article includes a section about “The future of psilocybin in Canada,” in which Jordan Donich, a Toronto-based criminal lawyer discusses the future for legalizing magic mushrooms.

The article’s discussion of the product dosing is also confusing.  According to the Yahoo article, “Larsen explains that the shop sells 25 ml, 50 ml and 100 ml doses – about five to 10 per cent of what you’d take if you wanted to experience hallucinations.”  These milliliter quantities make sense for neither psilocybin (the chemical) nor any mushroom material containing it. Milliliters describe units of volume whereas psilocybin and mushrooms are both solid materials, which would be measured in grams (or milligrams).

See also Three Key Points of Journalists Reporting on Magic Mushrooms or Psilocybin.

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Chemical & Engineering News Discusses Entourage Effect https://psilocybintechnology.com/chemical-engineering-news-discusses-entourage-effect/ https://psilocybintechnology.com/chemical-engineering-news-discusses-entourage-effect/#comments Tue, 23 Jul 2019 19:57:16 +0000 https://psilocybintechnology.com/?p=2316 A July 21, 2019 article in the American Chemical Society’s Chemical & Engineering News by Britt E. Erickson discussed the importance of the Entourage Effect in cannabis health. Like magic mushroom ...

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A July 21, 2019 article in the American Chemical Society’s Chemical & Engineering News by Britt E. Erickson discussed the importance of the Entourage Effect in cannabis health.

Like magic mushroom fruiting bodies, cannabis plant material includes multiple active ingredients (cannabinoids, terpenoids, and other “minor components”), which modulate its biological and clinical properties. Often, taking a combination of those active ingredients is better than taking only one of them. Similar to how natural mushrooms offer benefits over pure psilocybin, full spectrum cannabis products (or formulations) provide benefits over single active ingredients, like pure THC or pure CBD. See also Psilocybin Formulations. See Cannabis v Magic Mushrooms Analogy.

From the article:

“Whole-plant extracts not only are more effective but also have fewer side effects than pure CBD at higher doses, Russo says. The bottom line, he says, is that “whole-cannabis extracts are going to have an advantage over pure compounds in almost every instance.”

Ms. Erickson’s article is consistent with Rolling Stone’s indication that the future of the cannabis industry will come from formulations. 

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