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Bionomics Initiates AFFIRM-1, a Phase 3 Clinical Trial with BNC210 for Social Anxiety Disorder
Topline results are expected in Q3 2025 ADELAIDE, Australia and CAMBRIDGE, Mass., July 18, 2024 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX)
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[{"type":"text","content":"Topline results are expected in Q3 2025 ADELAIDE, Australia and CAMBRIDGE, Mass., July 18, 2024 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a biotechnology company developing novel, potential 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 initiation of 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). “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.”, said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “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.” AFFIRM-1 targets enrollment of 330 adult patients with SAD at clinical sites in the United States (U.S.). It is a multi-center, double-blind, two-arm, parallel group, placebo-controlled trial. Participants will be randomized 1:1 to receive a single dose of 225 mg BNC210 or matched placebo about one hour before speaking in public. The primary endpoint will compare BNC210 to placebo using the Subjective Units of Distress Scale (SUDS) to measure self-reported anxiety levels during a public speaking task. Secondary efficacy endpoints include the Clinical and Patient Global Impression (CGI and PGI, respectively) scales and the State-Trait Anxiety Inventory (STAI). BNC210 is an α7 nicotinic receptor small molecule with a unique and differentiating profile that is fast-acting, non-sedating, non-addictive and non-cognition impairing, and is suitable for both acute and chronic administration in neuropsychiatric disorders. The Phase 3 initiation of AFFIRM-1 follows results from the full data analysis of the Phase 2 PREVAIL study and the End-of-Phase 2 (EoPh2) meeting with the U.S. Food and Drug Administration (FDA) in Q3 2023 dur...