Bionomics Reports Successful End-of-Phase 2 FDA Meeting on BNC210 for PTSD Development

Bionomics Limited, a clinical-stage biotechnology company based in Adelaide, Australia, and Cambridge, Massachusetts, has announced favorable outcomes from a crucial End-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA). This milestone supports the advancement of Bionomics' lead asset, BNC210, into Phase 3 trials for the treatment of post-traumatic stress disorder (PTSD), based on positive results from the recently completed Phase 2b ATTUNE study.

Dr. Spyros Papapetropoulos, President and CEO of Bionomics, expressed enthusiasm about the outcomes of the EoP2 meeting and the company’s transition towards becoming a pre-commercial organization. He highlighted BNC210's strong clinical profile, which has shown efficacy across various stress and anxiety disorders. Papapetropoulos believes that BNC210 has the potential to transform PTSD treatment standards, a disorder affecting approximately 7% of Americans during their lifetime. Following the recent initiation of a Phase 3 trial of BNC210 in social anxiety disorder (AFFIRM-1), Bionomics plans to begin a Phase 3 trial for PTSD by the end of 2024.

The company's clinical plans for registration include conducting a single additional Phase 3 trial to evaluate two dose levels of BNC210. This trial will be a 12-week randomized, double-blind, placebo-controlled study, complemented by a 52-week open-label extension. The EoP2 meeting, which took place on June 26, 2024, focused on the design of the Phase 3 trial, which, if successful, could lead to the review of a New Drug Application (NDA) submission.

Key agreements from the meeting included using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) as the primary endpoint measure and the Clinical Global Impressions Severity scale (CGI-S) as a secondary endpoint measure. Additionally, it was decided that alongside the 900 mg twice daily dose, a lower dose of 600 mg twice daily would be tested. This lower dose aims to balance efficacy and safety concerning liver function tests (LFT) findings. High-level agreements on participant characteristics and sample size assumptions were also made. Furthermore, the FDA provided guidance on hepatic safety monitoring plans, including monitoring for excessive alcohol use during the Phase 3 trial.

Bionomics plans to submit the full Phase 3 protocol for FDA review before initiating the trial. The company is currently finalizing the study protocol and anticipates starting the Phase 3 program for PTSD in the fourth quarter of 2024.

BNC210, formulated as an oral solid tablet, is a negative allosteric modulator of the α7 nicotinic acetylcholine receptor. It is under development for treating social anxiety disorder (SAD) and PTSD. The FDA has granted BNC210 Fast Track designation for the acute treatment of SAD and other anxiety-related disorders, as well as for the treatment of PTSD and other trauma and stressor-related disorders.

Bionomics is a clinical-stage biotechnology company developing novel, potentially first-in-class, allosteric ion channel modulators to treat patients with serious central nervous system (CNS) disorders with high unmet medical needs. Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc. (MSD outside the United States and Canada) involving two drugs in early-stage clinical trials for cognitive deficits in Alzheimer’s disease and other CNS conditions. The company's pipeline also includes preclinical assets targeting Kv3.1/3.2 and Nav1.7/1.8 ion channels for CNS conditions with high unmet needs.

In conclusion, Bionomics' recent FDA meeting marks a significant step forward for BNC210, moving the company closer to potentially offering a new treatment option for PTSD. The planned Phase 3 trial, set to begin in late 2024, will be crucial in determining the drug's future and its potential to change the standard of care for PTSD patients.