Bionomics Initiates AFFIRM-1, a Phase 3 Clinical Trial with BNC210 for Social Anxiety Disorder

Core Insights - Bionomics has initiated the Phase 3 AFFIRM-1 trial for BNC210, targeting social anxiety disorder (SAD), following a successful capital raise and a strong clinical development team [2][9] - The trial aims to enroll 330 adult patients with SAD and will evaluate the safety and efficacy of BNC210 as an acute treatment option [10][11] - BNC210 is a novel small molecule that acts as a negative allosteric modulator of the α7 nicotinic receptor, designed to be fast-acting, non-sedating, and non-addictive [3][13] Company Overview - Bionomics Limited is a biotechnology company focused on developing innovative treatments for serious central nervous system (CNS) disorders with high unmet medical needs [9][14] - The company is advancing BNC210 for both acute treatment of SAD and chronic treatment of post-traumatic stress disorder (PTSD) [13][14] - Bionomics has received FDA Fast Track designation for BNC210 for both SAD and PTSD, indicating its potential as a first-in-class treatment [11][13] Trial Details - The AFFIRM-1 trial is a multi-center, double-blind, placebo-controlled study, with participants randomized to receive either 225 mg of BNC210 or a matched placebo [10][11] - The primary endpoint is to measure changes in self-reported anxiety levels during a public speaking task using the Subjective Units of Distress Scale (SUDS) [10][11] - Secondary endpoints include various anxiety assessment scales, such as the Clinical Global Impression (CGI) and the State-Trait Anxiety Inventory (STAI) [10][11] Market Context - Social anxiety disorder is a prevalent mental health condition, affecting an estimated 31 million Americans at some point in their lives, highlighting the significant market potential for effective treatments [12]