Bionomics Limited (Nasdaq: BNOX) is making significant strides in its clinical and corporate development, highlighted by the advancement of its lead drug candidate, BNC210, into a Phase 3 trial for social anxiety disorder (SAD). The company also anticipates a Phase 2 entry for its Alzheimer's disease program through a strategic partnership with Merck & Co.
BNC210 Phase 3 Trial for Social Anxiety Disorder
Following successful regulatory interactions, Bionomics has initiated its first Phase 3 trial for BNC210 in SAD. BNC210, an oral, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, has shown promising clinical study outcomes. The company anticipates a data readout from this trial in Q3 2025. BNC210 has also secured FDA Fast Track designation for acute treatment of SAD and other anxiety-related disorders.
Strategic Partnership with Merck & Co.
Bionomics' strategic partnership with MSD (Merck & Co., Inc., Rahway NJ, USA) focuses on developing α7 receptor PAMs targeting cognitive dysfunction associated with Alzheimer’s disease and other central nervous system conditions. This collaboration, valued at approximately US $500 million, is progressing rapidly, with expectations to enter Phase 2 in the near future, triggering a substantial milestone payment for Bionomics.
Corporate Redomiciling and Launch of Neuphoria Inc.
Bionomics is in the final stages of redomiciling the company to the U.S. and launching Neuphoria Inc. This new entity will focus on a CNS pipeline, leveraging the U.S. biotechnology ecosystem while maintaining an Australian presence for potential tax benefits. As part of this process, Bionomics plans to consolidate its issued shares to remain compliant with NASDAQ listing rules.
BNC210 for PTSD
Bionomics is actively exploring ways to enhance efficiencies and potential partnerships to drive the Phase 3 trial of BNC210 in PTSD to a successful NDA submission with a single trial. Trial initiation activities have begun, and the Phase 3 trial in PTSD is expected to commence in the second half of 2025 or sooner, contingent upon successful financing. BNC210 also holds FDA Fast Track designation for the treatment of PTSD and other trauma and stressor-related disorders.
BNC210 has demonstrated a favorable safety database supporting a differentiated non-sedating, non-addicting profile and positive datasets in four separate anxiety and stress-related indications. These clinical datasets and designations give Bionomics the ability to leverage regulatory privileges that can potentially accelerate review and approval.
