Business
Bionomics Announces Successful End-of-Phase 2 Meeting with the FDA on the Development of BNC210 in Post-Traumatic Stress Disorder
Successful End-of-Phase 2 (EoP2) meeting with U.S. Food and Drug Administration (FDA) provides a potential path to New Drug Application (NDA) submission for
About this update from Neuphoria Therapeutics Inc.
[{"type":"text","content":"Successful End-of-Phase 2 (EoP2) meeting with U.S. Food and Drug Administration (FDA) provides a potential path to New Drug Application (NDA) submission for BNC210 for post-traumatic stress disorder (PTSD) with a single Phase 3 trialCompany received favorable FDA feedback on the Phase 3 study design and safety monitoring plans required for registrationCompany plans to initiate the Phase 3 program in Q4 2024A conference call and webcast presentation to discuss the outcomes will be held today at 8:00 a.m. ET, details below ADELAIDE, Australia and CAMBRIDGE, Mass., July 31, 2024 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced the favorable outcomes of an EoP2 meeting with the FDA, supporting the advancement of 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. “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,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “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.” The company presented the clinical plans to registration, that alongside the positive Phase 2b ATTUNE trial include a single additional Phase 3 trial to evaluate two dose levels of BNC210 in a 12-week randomized, double-blind, placebo-controlled trial with a 52-week open-label extension. The meeting, held on June 26, 2024, was centered around the design of the Phase 3 trial that if successful may enable review of the NDA submission. Key outcomes from the discussion on the trial design included: Agreement was reached on the use of C...