Bionomics Starts Phase 3 Trial of BNC210 for Social Anxiety

Bionomics Limited, a biotechnology company listed on Nasdaq (BNOX), has announced the initiation of patient screening for its Phase 3 AFFIRM-1 trial. This trial aims to evaluate the safety and efficacy of BNC210, a drug designed for the acute, on-demand treatment of social anxiety disorder (SAD). The company, which is based in Adelaide, Australia, and Cambridge, Massachusetts, is recognized for developing novel allosteric ion channel modulators for central nervous system (CNS) disorders with significant unmet medical needs.

The AFFIRM-1 trial represents a significant milestone for Bionomics as it advances into the Phase 3 clinical stage. According to Dr. Spyros Papapetropoulos, the President and CEO of Bionomics, the trial's initiation was made possible by a recent capital raise and the expertise of the company's clinical development team. The goal is to transform the treatment paradigm for millions of individuals who currently lack safe and effective acute, on-demand treatment options for anxiety-inducing situations.

AFFIRM-1 plans to enroll 330 adult patients diagnosed with SAD across multiple clinical sites in the United States. It is a double-blind, placebo-controlled trial in which participants will be randomized 1:1 to receive either a single dose of 225 mg BNC210 or a matched placebo approximately one hour before a public speaking task. The primary endpoint will measure self-reported anxiety levels using the Subjective Units of Distress Scale (SUDS). Secondary endpoints include measures from the Clinical and Patient Global Impression scales (CGI and PGI, respectively) and the State-Trait Anxiety Inventory (STAI).

BNC210 is an α7 nicotinic receptor small molecule with a unique profile. It is fast-acting, non-sedating, non-addictive, and does not impair cognition, making it suitable for both acute and chronic administration in neuropsychiatric disorders. The decision to move forward with the Phase 3 trial follows the successful results of the Phase 2 PREVAIL study and an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in Q3 2023. This meeting established the roadmap for a future New Drug Application (NDA) submission for BNC210.

Beyond treating SAD, BNC210 has shown promise in reducing panic symptoms, general anxiety levels, and the overall severity of symptoms in post-traumatic stress disorder (PTSD). Dr. Papapetropoulos emphasized the company's commitment to advancing BNC210, which has received FDA Fast Track designation for both SAD and PTSD. He also mentioned that updates regarding the PTSD program would be shared following the recent End-of-Phase 2 meeting with the FDA.

The AFFIRM-1 trial is designed to enroll approximately 330 adult patients diagnosed with SAD who score at least 60 on the Liebowitz Social Anxiety Scale (LSAS). Participants will receive either 225 mg of BNC210 or a placebo one hour before a public speaking challenge. The primary endpoint is the change in SUDS scores from baseline to the performance phase of the public speaking task. Secondary endpoints include changes in SUDS scores during the anticipation phase, alterations in the Clinical Global Impression – Severity scale, and self-assessments using the State-Trait Anxiety Inventory and the Patient-Global Impression - Improvement scale. A follow-up visit will occur one week after the public speaking challenge.

Social Anxiety Disorder (SAD) is characterized by a significant and persistent fear of social and performance-related situations. It is one of the most common mental disorders in the United States, affecting approximately 31 million Americans at some point in their lives. SAD can severely impact a person's ability to work, maintain relationships, and engage in everyday activities.

BNC210 is an oral tablet that acts as a negative allosteric modulator of the α7 nicotinic acetylcholine receptor. It is under development for the treatment of SAD and PTSD and has received FDA Fast Track designation for these conditions.

Bionomics is a clinical-stage biotechnology company focused on developing novel allosteric ion channel modulators for CNS disorders with high unmet medical needs. The company is advancing BNC210 for the treatment of SAD and PTSD, while also collaborating with Merck & Co., Inc. on early-stage clinical trials for cognitive deficits in Alzheimer's disease and other CNS conditions. Bionomics' pipeline includes preclinical assets targeting Kv3.1/3.2 and Nav1.7/1.8 ion channels for CNS conditions.