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Bionomics Publishes the Positive Results from the Phase 2 ATTUNE Study of BNC210 in Patients with Post-Traumatic Stress Disorder in NEJM Evidence
BNC210 improved PTSD symptom severity at Week 12 with efficacy observed as early as Week 4Company plans to initiate a Phase 3 study of BNC210 in PTSD in H2
About this update from Neuphoria Therapeutics Inc.
[{"type":"text","content":"BNC210 improved PTSD symptom severity at Week 12 with efficacy observed as early as Week 4Company plans to initiate a Phase 3 study of BNC210 in PTSD in H2 2025 ADELAIDE, Australia, and CAMBRIDGE, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced that the positive results from its Phase 2 ATTUNE study have been published in the NEJM Evidence. The data were also presented yesterday at the 63ʳᵈ Annual Meeting of the American College of Neuropsychopharmacology (ACNP) as part of the inaugural “Promising Targets” session. “We are excited to publish the results of the ATTUNE in NEJM Evidence, a prestigious journal for innovative original research. This peer-reviewed publication further validates these significant results and underscores the differentiated clinical profile of BNC210, a potential best- and first-in class treatment for PTSD that is non-psychedelic, non-sedating and non-habit-forming,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “Since our successful End-of-Phase 2 meeting with the FDA earlier this year, we have been diligently preparing for the Phase 3 study of BNC210 in PTSD which we anticipate initiating in the second half of 2025, if not sooner.” Key results from the publication include: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score improvement was observed with BNC210 compared with placebo (p=0.048) at Week 12 with improvement seen as early as Week 4Clinically meaningful and statistically significant improvements were also observed with BNC210 vs placebo in: Depressive symptoms measured on the Montgomery–Åsberg Depression Rating ScaleSleep measured on the Insomnia Severity Index Treatment-emergent adverse events (AEs) occurred in 70 (66.7%) patients in the BNC210 group and 56 (53.8%) in the placebo group. The most common AEs were headache, nausea, fatigue, and hepatic enzyme elevations. “This publication highlights the encouraging and clinically meaningful improvements seen with BNC210 across several key PTSD symptoms,” commented Murray B Stein, M.D., M.P.H.; Distinguished Professor of Psychia...