Bionomics Kicks Off Phase 3 Trial for Promising Social Anxiety Disorder Treatment

• Bionomics Limited (Nasdaq: BNOX) has begun patient screening for its Phase 3 AFFIRM-1 clinical trial, evaluating the safety and efficacy of BNC210 for the acute, as-needed treatment of social anxiety disorder (SAD). BNC210 is an α7 nicotinic receptor small molecule that is fast-acting, non-sedating, non-addictive, and non-cognition impairing, suitable for both acute and chronic use in neuropsychiatric disorders. This Phase 3 trial follows the successful Phase 2 PREVAIL study and an End-of-Phase 2 meeting with the FDA, setting the stage for a future NDA submission. BNC210 has FDA Fast Track designation for both SAD and PTSD. The company recently completed a private placement of up to $70 million to support this clinical development. An estimated 7.1% of U.S. adults had social anxiety disorder in the past year.

Key Highlights:

• Study Design: AFFIRM-1 is a multi-center, double-blind, placebo-controlled trial targeting 330 adult patients with SAD in the U.S. Participants will receive a single dose of 225 mg BNC210 or placebo before a public speaking task.
• Primary Endpoint: The trial will use the Subjective Units of Distress Scale (SUDS) to measure self-reported anxiety levels during public speaking, comparing BNC210 to placebo.
• Secondary Endpoints: Additional measures include the Clinical and Patient Global Impression scales and the State-Trait Anxiety Inventory.

Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics, stated, “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.”