Bionomics Announces Positive Phase 2b ATTUNE Trial Outcomes for BNC210 in PTSD

Bionomics Limited, a clinical-stage biotechnology firm, has reported positive outcomes from its Phase 2b ATTUNE trial of BNC210 for treating post-traumatic stress disorder (PTSD). The study showed that BNC210 significantly reduced PTSD symptom severity with a rapid onset and sustained effect, and was well-tolerated by patients. BNC210 is a novel, non-psychedelic therapeutic with a unique mechanism of action, offering a potential advantage over current SSRI treatments, which have a slower onset and more side effects.

The ATTUNE trial met its primary endpoint, demonstrating a statistically significant improvement in PTSD symptoms compared to a placebo. Notably, the drug showed efficacy as early as the fourth week of treatment, which aligns with its mechanism of action. BNC210 also achieved significant results for intrusion symptoms and negative mood alterations, key components of PTSD management. Additionally, it improved depressive symptoms and sleep quality, which are secondary endpoints.

Safety results indicate that BNC210 has a favorable profile, with most adverse events being mild or moderate. No serious adverse events were reported, and common side effects were headache, nausea, fatigue, and slight increases in hepatic enzymes. Importantly, there were no sexual side effects, which are often associated with SSRIs.

Pharmacokinetics analyses revealed that BNC210's tablet formulation provided a predictable profile, exceeding therapeutic exposure levels for PTSD. The Company plans to discuss these results with the FDA and initiate a late-stage trial by the end of 2024.

BNC210 is being developed for the treatment of PTSD and Social Anxiety Disorder (SAD) and has received FDA Fast Track designation for these indications. Bionomics is also partnered with Merck & Co., Inc., to develop drugs for Alzheimer's disease and other CNS conditions.

Bionomics Limited is focused on developing first-in-class, allosteric ion channel modulators for serious CNS disorders with significant unmet needs. Their lead candidate, BNC210, is an oral, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor. The company's pipeline also includes preclinical assets targeting Kv3.1/3.2 and Nav1.7/1.8 ion channels for high-need CNS conditions.