PsyBio Therapeutics begins clinical trial site selection process

PsyBio Therapeutics is building a network of highly qualified local principal investigators to recruit and conduct future clinical trials

OXFORD, Ohio and COCONUT CREEK, Florida., April 13, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV:PSYB) (OTCQB:PSYBF) (“PsyBio“or the”Company“), an integrated, intellectual property-driven biotechnology company developing novel, tailor-made psychoactive medicinal candidates targeting the potential treatment of mental health conditions, neurological disorders and other human health conditions, today announces that it initiates the process of recruiting, evaluating and selecting highly qualified researchers for the next clinical trials.

“The site selection process is critically important to the success of clinical investigations,” said Michael Spigarelli, MD, PhD, MBA, Chief Medical Officer of PsyBio. “My experience managing thousands of studies as a former clinical trial investigator and trial site operator will allow PsyBio to develop partnerships with clinical trial site investigators and work collaboratively with qualified sites to ensure the highest quality data collection and the shortest timelines for clinical studies.While we have begun to discuss possible participation in future trials, other researchers still have the opportunity to participate if a qualified researcher or site seeks further information.

PsyBio is currently in the process of writing its second pre-IND application in anticipation of researching an investigational new drug (“INDIANA“) U.S. Food and Drug Administration approval (“FDA“) for future clinical trials. Once submitted and approved by the relevant regulatory authorities, including the FDA, clinical investigators will be selected and trained to conduct clinical investigations, which will facilitate the rapid start and completion of trials. .

“The ability to initiate clinical trials with our easily manufacturable and scalable psycho-targeted therapeutic candidates, once approved by regulatory authorities, reinforces PsyBio’s role as one of the only biotech companies in the psychoactive therapeutics industry. developing its own compounds from the bench to the bedside,” said Evan Levin, CEO of PsyBio. “Collaborating with committed and talented local researchers and utilizing their deep content knowledge will be invaluable to PsyBio as clinical trials are initiated, data analyzed and results reported.”

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is an integrated, intellectual property-driven biotechnology company that develops novel, tailor-made psychoactive medicinal candidates targeting the potential treatment of mental health conditions, neurological disorders and other human health conditions. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering, as well as clinical and regulatory expertise advancing drugs through human studies and regulatory protocols. Research and development is currently underway for naturally occurring psychoactive tryptamines originally discovered in different varieties of magic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company uses a biomedical chemistry approach to therapeutic development, in which psychoactive compounds can be used as a model on which to develop precursors and analogues, both natural and unnatural, particularly because they are already known to have an effect in the brain.

Caution Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities laws. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as of the date of this press release. Any statement that discusses future predictions, expectations, beliefs, plans, projections, goals, assumptions, events or performance (often, but not always using expressions such as “expects”, or “does not “, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “planned”, “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 expected to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements contained in this press release include statements regarding: plans and ability to recruit clinical investigators to future clinical trials; PsyBio’s ability to initiate clinical trials; PsyBio’s plans and ability to complete its clinical site selection process; PsyBio’s plans to submit a second pre-IND application to the FDA; PsyBio’s ability to develop new formulations to potentially treat neurological and psychological conditions and other disorders; PsyBio’s ability to develop its intellectual property portfolio of new drug candidates; the ability to achieve synthesis at a competitive cost with reduced environmental impact compared to current production methods; and PsyBio’s ability to move target candidates into large-scale commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be successful in recruiting highly qualified investigators for clinical evaluations; PsyBio will submit a second pre-IND application to the FDA; PsyBio will receive FDA approval to initiate clinical trials; clinical investigators will be trained to conduct clinical investigations; clinical investigations will help facilitate the rapid start and completion of trials; PsyBio will succeed in protecting its intellectual property; PsyBio will succeed in discovering interesting new target molecules; PsyBio will be successful in obtaining Investigational New Drug applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will succeed in launching clinical trials; the results of preclinical safety and efficacy tests will be favorable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in the indications selected by PsyBio; 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 cannot guarantee that the expectations in such forward-looking information will prove to be correct. Known and unknown risks, uncertainties and other factors that may cause actual results and future events to differ materially from those expressed or implied by such forward-looking information. These factors include, but are not limited to: compliance with numerous government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; the reduction of the process in force for psilocybin and nutraceuticals in the markets in which PsyBio operates; the impact of COVID-19; general business, economic, competitive, political and social uncertainties; and the risk factors set out in the Company’s management report for the period ended December 31, 2021 and the annual information form of the Company dated March 2, 2022which are available under the Company’s profile on www.sedar.com. 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 undertakes no obligation to update or revise forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting this forward-looking information. -search for information or other.

PsyBio makes no medical, treatment or health benefit claims regarding the products offered by PsyBio. The FDA or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next-generation psychoactive compounds. The effectiveness of these products has not been confirmed by FDA-approved research. There is no guarantee 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 reference to the quality, consistency, efficacy and safety of potential products does not imply that PsyBio has verified it in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the necessary approvals or research to commercialize its business, it could have a material adverse effect on PsyBio’s performance and operations.

The TSX Venture Exchange (the “TSXV“) has neither approved nor disapproved of the contents of this press 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 the accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

For further information: Evan Levine, CEO, PsyBio Therapeutics Corp., t: 513.449.9585, e: [email protected]; Valter Pinto or Tim Regan, KCSA Strategic Communications, tel: 212.896.1254, e: [email protected]

Martin E. Berry