PsyBio Therapeutics Corp has announced the successful completion of its initial pre-Investigational New Drug (IND) application meeting with the US Food and Drug Administration (FDA) as part of the regulatory submission process.
The company said the focus of the pre-IND meeting was to discuss potential indications, manufacturing strategy, and obtain regulatory guidance as it 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 over its approach, PsyBio said. Based upon this initial discussion, the company said it intends to submit compound-specific pre-IND meeting requests to define manufacturing and clinical trial parameters, it added.
READ: PsyBio Therapeutics submits its first pre-IND application meeting request to FDA
"PsyBio was created to develop novel therapeutic candidates with the goal to help improve human health," the company’s chief medical officer Dr Michael Spigarelli said in a statement.
"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,” he added.
PsyBio said the initial pre-IND meeting marks the company’s formal entry into the regulatory process, which it said is “paramount and of foremost importance” as part of its commitment to being a leader in developing psycho-targeted therapeutic candidates.
“The FDA has provided invaluable guidance which the company plans to heed and implement during the development period,” CEO Evan Levine said.
“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."
Ohio- and Florida-based 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.
Contact the author at stephen.gunnion@proactiveinvestors.com