PsyBio Therapeutics Corp. (TSXV: PSYB), an intellectual property driven biotechnology company focused upon discovery and development of new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health, today announced the successful completion of its initial pre-Investigational New Drug application meeting with the United States Food and Drug Administration as part of the regulatory submission process.
“PsyBio was created to develop novel therapeutic candidates with the goal to help improve human health,” “To achieve this goal, regulatory approval for any potential therapeutic candidate is absolutely necessary to bring that product to the patients who may benefit. As such, it is critically important to have open discussions, such as this meeting, with regulatory officials to most efficiently and effectively follow all requirements and guidance to facilitate future approvals.”
Dr. Michael Spigarelli, PsyBio’s Chief Medical Officer
The focus of this pre-IND meeting was to discuss potential indications, manufacturing strategy, and obtain regulatory guidance as PsyBio guides its technology forward towards regulatory approval. The responses received from the FDA to these initial set of questions were constructive and no changes were proposed with respect to PsyBio’s approach. Based upon this initial discussion, PsyBio intends to submit compound specific pre-IND meeting requests to define manufacturing and clinical trial parameters.
“This initial pre-IND meeting marks our formal entry into the regulatory process, which is paramount and of foremost importance to PsyBio as part of our commitment to being a leader in developing psycho-targeted therapeutic candidates,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The FDA has provided invaluable guidance which the Company plans to heed and implement during the development period. We look forward to collaborating with the FDA and other regulatory agencies to demonstrate our potential therapeutic candidates are safe and effective for their proposed indications.”
About PsyBio Therapeutics Corp.
PsyBio is an intellectual property driven biotechnology company focusing on discovering and developing new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health. 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.