Bionomics Begins Phase 3 AFFIRM-1 Clinical Trial with BNC210

July 18, 2024

DENVER, Colo., Jul 18, 2024 (247marketnews.com)- Bionomics Limited (Nasdaq: BNOX) stated that it began patient screening for the Phase 3 AFFIRM-1 trial evaluating the safety and efficacy of BNC210 for the acute, as-needed treatment of social anxiety disorder (SAD) and it expects topline results in the third quarter of 2025.

Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics, commented, “AFFIRM-1 trial initiation marks a major achievement for Bionomics as we enter the Phase 3 clinical stage, made possible by our recent capital raise and our expert clinical development team that has a proven track record of executing high quality trials on time and within budget.

“The Phase 3 study expands on the findings of the Phase 2 PREVAIL trial and brings us closer to potentially transforming the treatment paradigm for the millions of individuals who lack safe and effective acute, as-needed treatment options to assist them in facing anxiety-inducing situations.

“We remain committed to advancing BNC210, a potential first- and best-in-class candidate with FDA Fast Track designation for both SAD and PTSD and look forward to sharing an update about our PTSD program following the recently completed EoPh2 meeting with the FDA.”

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