Neuphoria Therapeutics Completes Target Enrollment in Phase 3 AFFIRM-1 Trial of BNC-210 in Social Anxiety Disorder (SAD)

Core Insights - Neuphoria Therapeutics Inc. has achieved target enrollment of 332 participants in the AFFIRM-1 Phase 3 trial for BNC-210, a treatment for social anxiety disorder (SAD), with topline data expected in early Q4 2025 [1][2] Company Overview - Neuphoria is a clinical-stage biotechnology company focused on developing therapies for neuropsychiatric disorders, with BNC-210 as its lead candidate [5] - BNC-210 is an oral, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, designed for acute treatment of SAD and post-traumatic stress disorder (PTSD) [2][5] - The company has received FDA Fast Track designation for BNC-210 for the treatment of SAD and PTSD [2] Clinical Trial Details - The AFFIRM-1 trial is a multi-center, double-blind, placebo-controlled study evaluating a single dose of 225 mg of BNC-210 [3] - The primary endpoint is the change in Subjective Units of Distress Scale (SUDS) scores from baseline to the performance phase of a public speaking challenge [3] - Secondary endpoints include changes in SUDS scores during the anticipation phase, Clinical Global Impression – Severity (CGI-S) scale, State Trait Anxiety Inventory (STAI-State), and Patient Global Impression – Improvement (PGI-I) scale [3] Market Context - Social Anxiety Disorder (SAD) affects an estimated 31 million Americans, making it one of the most common mental disorders in the U.S. [4] - SAD can significantly impact daily life, including work, relationships, and social activities [4]