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PsyBio and Miami University Broaden Partnership Agreement for the Continued Advancement of its Neuropsychiatric Drug Discovery Platform, Expediting its IND Submission to the FDA

OXFORD, Ohio and COCONUT CREEK, Fla., April 26, 2021 /CNW/ — PsyBio Therapeutics Corp. (TSXV:PSYB) (“PsyBio” or the “Company“), a biotechnology company pioneering the next generation of targeted psychoactive medications, announces today that it has amended its master sponsored agreement with Miami University based in Oxford, Ohio (the “Amended Agreement“) to extend and expand the research efforts of the laboratory of Dr. J. Andrew Jones in the Department of Chemical, Paper, and Biomedical Engineering (the “Jones Lab“), to include additional research efforts of the laboratory of Dr. Matthew McMurray in the Department of Psychology (the “McMurray Lab“), and to provide an additional US$1.5 million in funding until May 2023 to Miami University to support all such research.

This continued collaboration with Miami University is anticipated to expediate progress towards the filing of an Investigational New Drug (“IND“) application with the US Food and Drug Administration (“FDA“).

“The initial collaboration between PsyBio and Miami University has resulted in the discovery and scaled production of two medically-relevant tryptamine molecules that are naturally present in psychoactive magic mushrooms, psilocybin and norbaeocystin. The compounds have been efficiently synthesized and further studied in our labs and have now moved out of our labs into venerated commercial development facilities,” stated Evan M. Levine, CEO of PsyBio. “PsyBio believes that it can synthesize these molecules cheaper, faster, and greener than any other published method, and is unaware of any other biotechnology company synergistically developing these natural alkaloids with the intent of commercial medical use. We have filed intellectual property on the preliminary synergistic properties of these natural alkaloids, and PsyBio is developing a portfolio of similar and various intermediates and combinations thereof in multiple plants, fungi and non-natural substrates, with the endeavor for the study of and testing for improved human clinical treatment.”

“We are extraordinarily fortunate to have the resources and relationships at Miami University to attract institutional investment capital that is interested in advancing a paradigm shift in the potential treatment of mental health,” stated Dr. J. Andrew Jones, Chairman of PsyBio’s Scientific Advisory Board (“SAB“) and Assistant Professor at Miami University. “Our work with the McMurray Lab and PsyBio is expected to enable the Jones Lab’s discoveries to advance from discovery to in vivo validation and industrial application, ultimately with a goal of shortening the time between potential discovery and treatment of patients, once all necessary approvals have been obtained and safety and efficacy proven.”

“I am extraordinarily excited to bring my unique skills and resources to this collaboration between PsyBio and Miami University,” stated Dr. Matthew McMurray, Member of PsyBio’s SAB and Assistant Professor of Psychology at Miami University. “I bring my expertise in cognitive neuroscience, neuropsychopharmacology, and biopsychology, along with my extensive experience in animal models of mental health disorders to incorporate broad animal studies in combination with Dr. Jones’ biosynthetic production platform. Together, I believe we are leading a paradigm shift in drug development and potential neuropsychiatric treatment.”

Pursuant to the terms of the initial master sponsored agreement with Miami University dated May 14, 2020, PsyBio acquired the global, exclusive, and perpetual right to license a platform technology developed in the Jones Lab that enables the rapid generation of its formulation for its lead compound psilocybin, biosynthetic psilocybin, and other targeted tryptamines through a biosynthetic process using genetically modified bacteria. Under the Amended Agreement, the Jones Lab plans to develop elite microbes capable of efficient production of a range of medically-relevant alkaloids. The compounds of interest originate from a variety of plants and fungi, including magic mushrooms. Additionally, Dr. J. Andrew Jones and his research team are expanding efforts to study and produce compounds that do not exist in nature, but based on their ongoing studies, have demonstrated early indications of unique therapeutic characteristics predicted by structural similarity to known bioactive compounds.

The McMurray Lab plans to conduct a myriad of IND-enabling, animal behavioral studies to verify the antidepressant, anxiolytic, anti-addictive effects of the alkaloids produced in the Jones Lab using both adult and adolescent animal models of disease. These studies will be performed at Miami University and will screen leading drug candidates in preparation for human trials. Preliminary studies have already detected evidence of an unexpected synergy between psilocybin and norbaeocystin, and the Company has advanced both drug candidates to commercial process development. 

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 is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company is also researching and developing new non-naturally occurring molecular structures 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 and filing new patent applications within the next year; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in collaborating with the the McMurray Lab and Jones Lab as contemplated under the Amended Agreement; PsyBio will be successful in obtaining IND Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio’s technology will be safe and effective; PsyBio will be able to synthesize molecules cheaper, faster, and greener than any other published method; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. 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 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.

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.

SOURCE PsyBio Therapeutics Inc