ADELAIDE, Australia and CAMBRIDGE, Mass. - Bionomics Limited (NASDAQ:BNOX), a biotechnology firm, has announced positive results from its Phase 2b ATTUNE trial for the treatment of post-traumatic stress disorder (PTSD). The company's lead drug candidate, BNC210, demonstrated a statistically significant improvement in PTSD symptom severity compared to placebo, with an effect size of 0.40 at Week 12 of the trial.
The ATTUNE trial met its primary endpoint, showing BNC210's potential for rapid onset and sustained efficacy in treating PTSD. The trial also reached several secondary endpoints, including improvements in depressive symptoms and sleep quality.
Bionomics plans to discuss BNC210's registrational program with the U.S. Food and Drug Administration (FDA) in the second quarter of 2024 and anticipates initiating a late-stage trial by the end of the year.
BNC210's safety and tolerability profile was highlighted as a differentiator from current treatments, with the majority of adverse events reported being mild or moderate. No serious adverse events were associated with BNC210, and the drug did not exhibit typical psychoactive treatment side effects, such as withdrawal symptoms or rebound anxiety.
The company's CEO, Dr. Spyros Papapetropoulos, emphasized the need for new PTSD treatments, citing the limited effectiveness of current selective serotonin reuptake inhibitors (SSRIs). BNC210's non-psychedelic, novel mechanism of action has shown promise in addressing this gap.
The trial's pharmacokinetics analysis indicated that BNC210's solid tablet formulation achieved the projected therapeutic exposures for PTSD. The company also plans to test a lower dose of BNC210 to mitigate hepatic enzyme elevations observed at the higher dose.
BNC210 has received the FDA Fast Track designation for the treatment of PTSD and Social Anxiety Disorder (SAD). Bionomics' broader pipeline includes collaborations with Merck & Co., Inc. and preclinical assets targeting ion channels for CNS conditions.
This news is based on a press release statement from Bionomics and does not reflect any additional analysis or opinion.
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