PsyBio Therapeutics Initiates Pilot Scale Development of Proprietary Biosynthetic Psilocybin with Global Contract Research, Development and Manufacturing Organization

OXFORD, Ohio and COCONUT CREEK, Fla., March 02, 2021 (GLOBE NEWSWIRE) — PsyBio Therapeutics Corp. (TSXV:PSYB) (“PsyBio” or the “Company”), a leader in the field of psychedelic research and drug development, has initiated pilot scale-up of its proprietary biosynthetic formulation of psilocybin in collaboration with Albany Molecular Research Inc. (“AMRI”), a leading global provider of advanced contract research, development and manufacturing solutions, with expertise in synthetic biology and fermentation development. The Company has completed Phase I of this process, including technology transfer activities, preparation of strain banks, and the adoption of analytical methods and looks forward to communicating additional progress.

“We are pleased to have moved our first production process from the laboratories of Dr. J. Andrew Jones at Miami University to a commercial development facility to scale production of our proprietary biosynthetic psilocybin ahead of clinical trials,” said Evan Levine, Chief Executive Officer of PsyBio. “Our proprietary platform technology allows our Company to generate high concentrations of psilocybin without needing to incorporate the actual fungus or rely on toxic and costly chemical synthesis reagents. Our methods to produce psilocybin and other tryptamines are expected to result in cheaper, faster and cleaner products than any other published methods.”

Pharmaceutical grade psilocybin is currently being produced for clinical trials and research activities using a chemical synthesis process. This method uses reagents such as heavy metal catalysts and toxic solvents, creates multiple unstable reaction intermediates, and undergoes numerous purification steps resulting in low carbon yield. This long reaction scheme takes approximately 5 to 15 days. The published literature on this process also states that the active pharmaceutical ingredient costs approximately US$2,000 per gram and attempting to purchase research grade psilocybin garners prices between approximately US$7,000 to US$10,000 per gram.⁽¹⁾ PsyBio has developed a biosynthetic process using readily available materials, which undergoes a two to four day, one pot autocatalytic process. The result is a product with high temperature stability and the pre-purified material currently costs approximately US$10 per gram to produce.

J. Andrew Jones, Ph.D., Chairman of the Company’s Scientific Advisory Board, added, “I’m excited to see one of my lab’s discoveries moving towards commercialization. Our talented team’s unwavering commitment has continued to energize us to reach this significant milestone on our way to developing a transformative potential therapy for millions of patients worldwide.”

The underlying technology was developed at Miami University by a team led by Dr. Jones, a faculty member in the Department of Chemical, Paper, and Biomedical Engineering. This technology is expected to enable the sustainable production of promising tryptamine drug candidates by fermentation of genetically engineered bacteria and is exclusively licensed to PsyBio on a worldwide, exclusive, perpetual basis, subject to the terms of the licensing and master sponsored research agreement dated May 14, 2020 between the Company and Miami University. 

About PsyBio Therapeutics Corp.

PsyBio is a biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria for the treatment of mental health and other disorders. The team has experience in drug discovery based on synthetic biology as well as clinical and regulatory experience moving drugs through human studies and regulatory protocols. Research and development are currently ongoing for naturally occurring tryptamines found in different varieties of magic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company is also researching and developing new molecular structures that do not occur in nature which may have unique therapeutics properties.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be successful in protecting its intellectual property within the next year and filing new patent applications within that timeframe; the Company’s success in discovering new valuable target molecules; the ability of PsyBio to obtain Investigation New Drug Applications; receipt of all necessary approvals for clinical trials; anticipated production costs; and the safety and efficacy of PsyBio’s technology and that such technology will be cheaper, faster and greener than other published methods. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The U.S. Food and Drug Administration (the “FDA”) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products have not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

Note:

(1) Source: Matthew Johnson, Professor of Psychiatry and Behavioural Sciences at John Hopkins University, as reported by Vice (May 26, 2020).

For further information contact: 

Evan Levine 
CEO, PsyBio Therapeutics Corp. 
t: 226.286.0348
e: ir@psybiolife.com

Media Enquiries:

Kirsten Frazer, PhD
LifeSci Communications
t: 646.863.0222
e: kfrazer@lifescicomms.com

The TSX Venture Exchange (the “TSXV”) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.