Bionomics Limited (NASDAQ: BNOX), a clinical-stage biotechnology firm, announced Wednesday that it has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its upcoming Phase 3 trial for BNC210, a drug candidate for post-traumatic stress disorder (PTSD).
The company noted that the FDA's favorable response in a recent End-of-Phase 2 meeting has paved the way for a New Drug Application (NDA) submission following a single Phase 3 trial.
The Phase 3 program is expected to commence in Q4 2024. It will investigate the efficacy of two dose levels of BNC210 in a 12-week randomized, double-blind, placebo-controlled trial with a 52-week open-label extension.
The primary endpoint for the trial will be the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), with the Clinical Global Impressions Severity scale (CGI-S) as a secondary measure.
The company has reached an agreement with the FDA on key aspects of the trial design, including the use of CAPS-5 as the primary endpoint measure, a lower dose option for BNC210 to balance efficacy and safety, and the methodology for determining study participant characteristics and sample size assumption. Bionomics also received guidance on a hepatic safety monitoring plan, which will include monitoring for excessive alcohol use.
Bionomics is also developing BNC210 for the treatment of social anxiety disorder, with a Phase 3 trial already underway. The company's broader pipeline includes partnerships and preclinical assets targeting various central nervous system disorders.
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