Biotech Company Announces Successful End-of-Phase 2 Meeting With FDA For PTSD Treatment Development
Bionomics Announces Successful End-of-Phase 2 Meeting with the FDA on the Development of BNC210 in Post-Traumatic Stress Disorder.
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Bionomics Limited (Nasdaq: BNOX), a clinical-stage biotechnology company, has recently made strides in the development of its lead asset, BNC210, for the treatment of Post-Traumatic Stress Disorder (PTSD). The company announced the favorable outcomes of an End-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA), which supports the advancement of BNC210 into Phase 3 clinical trials.
Phase 2b ATTUNE Study and EoP2 Meeting
Bionomics is a biotechnology company focused on developing novel, first-in-class allosteric ion channel modulators. These modulators have the potential to treat patients suffering from various serious CNS disorders. BNC210, the company's leading asset, is an oral solid tablet designed as a negative allosteric modulator of the α7 nicotinic acetylcholine receptor. It is currently being developed for the treatment of both social anxiety disorder (SAD) and PTSD.
The successful completion of the Phase 2b ATTUNE study provided compelling evidence for the efficacy of BNC210 in treating PTSD. Following this, Bionomics engaged in an EoP2 meeting with the FDA on June 26, 2024, to discuss the design and implementation of the upcoming Phase 3 trials. The primary focus of the meeting was to establish a clear path towards the registration and potential approval of BNC210 for PTSD treatment. Critical agreements were reached during the EoP2 meeting, which will guide the design and execution of the Phase 3 trial:
Primary and Secondary Endpoint Measures:
The FDA approved the use of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) as the primary endpoint measure.
The Clinical Global Impressions Severity scale (CGI-S) was agreed upon as a key secondary endpoint measure in the placebo-controlled part of the study.
Dosage Levels and Safety:
The efficacious dose of 900 mg twice daily (BID) will be tested alongside a lower dose of 600 mg BID. The lower dose aims to balance efficacy while addressing safety concerns related to liver function tests (LFT) findings.
The final Phase 3 PTSD trial protocol will include full justification for the chosen lower dose.
Study Participant Characteristics and Sample Size:
High-level agreement was reached regarding the characteristics of study participants and the methodology for determining sample size assumptions.
Hepatic Safety Monitoring Plan:
The company received guidance on implementing a hepatic safety monitoring plan, including monitoring for excessive alcohol use, which will be incorporated into the planned Phase 3 trial.
With these agreements in place, Bionomics is finalizing the full study protocol and anticipates beginning the Phase 3 program for PTSD in the fourth quarter of 2024. The company plans to submit the complete Phase 3 protocol for FDA review prior to trial initiation, ensuring that all regulatory requirements are met.
Understanding PTSD and the Potential Impact of BNC210
Post-Traumatic Stress Disorder (PTSD) is a psychiatric condition that can arise after experiencing or witnessing traumatic events. Symptoms of PTSD can include flashbacks, severe anxiety, and uncontrollable thoughts about the event. The disorder affects approximately 7% of Americans at some point in their lives, highlighting the urgent need for effective treatments. BNC210, as a negative allosteric modulator of the α7 nicotinic acetylcholine receptor, offers a novel approach to treating PTSD. By targeting this specific receptor, BNC210 has the potential to alleviate symptoms of stress and anxiety without the side effects commonly associated with current PTSD medications. The promising results from the Phase 2b ATTUNE study underline the drug's efficacy and reinforce its potential to transform the standard of care for PTSD patients.
Bionomics' progress in developing BNC210 extends beyond PTSD. The company has also initiated a Phase 3 trial of BNC210 for social anxiety disorder (SAD) under the AFFIRM-1 study. This phase involves preparing for the commercial production and distribution of BNC210, pending successful trial outcomes and regulatory approval. The company's leadership, including President and CEO Spyros Papapetropoulos, M.D., Ph.D., expresses confidence in BNC210's clinical profile and its potential to meet the needs of patients with PTSD and other anxiety disorders.
The favorable outcomes of the End-of-Phase 2 meeting with the FDA represent a pivotal moment for Bionomics and its lead asset, BNC210. With the support of regulatory authorities, the company is poised to advance BNC210 into Phase 3 clinical trials for PTSD, moving closer to providing a much-needed treatment option for patients suffering from this debilitating condition. As Bionomics continues to finalize its study protocol and prepare for the initiation of the Phase 3 program, the potential impact of BNC210 on the landscape of PTSD treatment remains a hopeful prospect.
Disclaimer: The information in this article is for general informational purposes only. It is not intended as medical, legal, or financial advice. Readers should consult with professionals for specific guidance tailored to their needs.
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