PsyBio Therapeutics Initiates Clinical Trial Site Selection Process

PsyBio Therapeutics is developing a network of highly qualified, local principal investigators to recruit and conduct upcoming clinical trials

OXFORD, Ohio and COCONUT CREEK, Fla., April 13, 2022 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the "Company"), an integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today is announcing that it is initiating the process of recruiting, evaluating and selecting highly qualified investigators for upcoming clinical trials.

"The process of site selection is critically important to the success of clinical investigations," stated Michael Spigarelli, MD, PhD, MBA, PsyBio's Chief Medical Officer. "My experience running thousands of studies as a former clinical trial investigator and trial site operator will allow PsyBio to develop partnerships with the clinical trial site investigators and work in collaboration with qualified sites to ensure the highest quality data collection and the shortest timelines for clinical studies. While we have started to discuss potential participation in upcoming trials, there is still opportunity for other investigators to participate should a qualified investigator or site seek further information."

PsyBio is currently in the process of drafting its second pre-IND application in anticipation of seeking investigational new drug ("IND") approval from the United States Food and Drug Administration ("FDA") for upcoming clinical trials. Once submitted and approved by the appropriate regulatory authorities, including the FDA, clinical investigators will be selected and trained to conduct clinical investigations, which will help facilitate rapid trial initiation and completion.

"The ability to launch clinical trials with our readily manufacturable and scalable psycho-targeted therapeutic candidates, once regulatorily approved, furthers PsyBio's role as one of the only biotechnology companies in the psychoactive therapeutic industry developing their own compounds from bench to bedside," stated Evan Levine, PsyBio's Chief Executive Officer. "Collaborating with committed and talented local investigators and using their extensive content knowledge will be invaluable to PsyBio as clinical trials are begun, the data analyzed, and results reported."

PsyBio Therapeutics is an integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, 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 progressing 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 utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.

This press release contains statements that constitute "forward-looking information" ("forward-looking information") within the meaning of 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. Forward looking-statements in this press release include statements regarding: PsyBio's plans and ability to recruit clinical investigators for upcoming clinical trials; PsyBio's ability to launch 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 novel formulations to potentially treat neurologic and psychologic conditions and other disorders; PsyBio's ability to build its intellectual property portfolio of novel drug candidates; the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled 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 approval from the FDA to launch clinical trials; clinical investigators will be trained to conduct clinical investigations; clinical investigations will help facilitate rapid trial initiation and completion; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable 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 be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favourable; PsyBio's technology will be safe and effective; a confirmed signal will be identified in PsyBio's selected indications; 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; general business, economic, competitive, political and social uncertainties; and the risk factors set out in the Company's management discussion and analysis for the period ended December 31, 2021 and the Company's annual information form dated March 2, 2022, which 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 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 has 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 Corp.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2022/13/c5256.html