Bionomics Reports Successful End-of-Phase 2 Meeting with the FDA for BNC210 in Post-Traumatic Stress Disorder

July 31, 2024

DENVER, Colo., Jul 31, 2024 (247marketnews.com)- Bionomics Limited (Nasdaq: BNOX) reported positive results from its end-of-phase II meeting with the FDA, concerning its lead asset BNC210 for the treatment of PTSD into Phase 3 based on the positive results of the recently completed Phase 2b ATTUNE study.

Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics, commented, “We are very pleased with the outcomes of our EoP2 meeting with the FDA and look forward to initiating our transformation into a pre-commercial organization.

“This milestone is another testament to the strong clinical profile of BNC210, which has demonstrated efficacy across multiple stress and anxiety disorders. We believe BNC210 can potentially transform the standard-of-care in PTSD, a serious disorder impacting about 7% of Americans during their lifetime. Followings the recent initiation of the Phase 3 trial of BNC210 in social anxiety disorder (AFFIRM-1), we look forward to starting a Phase 3 trial in PTSD by the end of 2024.”

Bionomics plans to submit the full Phase 3 protocol for FDA review prior to trial initiation, which it anticipates will begin later this year.

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