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Bionomics Announces Successful End-of-Phase 2 Meeting with the FDA and Solidifies Plans to Initiate the Registrational Program for BNC210 in Social Anxiety Disorder
Positive outcome of End-of-Phase 2 meeting with U.S. Food and Drug Administration (FDA) in September 2023 enables advancement of BNC210 into Phase 3 studies
About this update from Neuphoria Therapeutics Inc.
[{"type":"text","content":"Positive outcome of End-of-Phase 2 meeting with U.S. Food and Drug Administration (FDA) in September 2023 enables advancement of BNC210 into Phase 3 studies in Social Anxiety DisorderCompany confirms agreement with the FDA on Phase 3 clinical program and alignment on nonclinical toxicology studies required for registrationCompany is on track for first patient dosed in the Phase 3 program planed for Q1’24 ADELAIDE, Australia, and CAMBRIDGE, Mass., Oct. 16, 2023 (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 successful and favorable outcomes of an End-of-Phase 2 meeting (EoP2) meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of its lead asset BNC210 for the acute treatment of Social Anxiety Disorder (SAD) into Phase 3 registrational studies based on the recently completed Phase 2 PREVAIL dataset. “We are grateful for FDA’s support and guidance and very pleased to reach an agreement on key elements of Phase 3 design and other nonclinical components required for registration”, said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “The FDA meeting outcomes provide external and independent validation of our position on the strength and Phase 3-enabling nature of the PREVAIL dataset. BNC210’s unique clinical profile seen in multiple anxiety disorders including SAD, Generalized Anxiety Disorder and in a panic model, was recently significantly enhanced by the positive results in Post-Traumatic Stress Disorder. BNC210, which has Fast-Track designation from the FDA for the acute treatment of SAD, has the potential to address a significant unmet need for the 17 million Americans suffering from SAD who currently don’t have fast acting and safe treatment options.” On October 11, Bionomics received the official meeting minutes from the EoP2 meeting with the FDA held on September 13, 2023 reflecting that Bionomics has reached an agreement with the FDA on:1) the plan to conduct two randomized, placebo-controlled studies with single administration of BNC210 during a public speaking task; 2) the use of the Subjective Units of Dist...