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Bionomics Reports Results of the Full Dataset Analysis from ATTUNE Phase 2b Trial of BNC210 in Patients with Post-Traumatic Stress Disorder
BNC210 demonstrated a statistically significant improvement in post-traumatic stress disorder (PTSD) symptom severity with a clinically meaningful effect size
About this update from Neuphoria Therapeutics Inc.
[{"type":"text","content":"BNC210 demonstrated a statistically significant improvement in post-traumatic stress disorder (PTSD) symptom severity with a clinically meaningful effect size suggesting a potential advantage over approved medications. BNC210’s emerging safety and tolerability profile continues to support its differentiation over approved, available, and experimental psychoactive treatments. Bionomics will meet with the U.S. Food & Drug Administration (FDA) to discuss BNC210’s registrational program in PTSD by end of the second quarter of 2024; Late-stage trial initiation is expected by the end of 2024. ADELAIDE, Australia and CAMBRIDGE, Mass., March 21, 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 the release of the full dataset analysis from its Phase 2b ATTUNE trial in patients with post-traumatic stress disorder. In September 2023, Bionomics reported the topline results for the Phase 2b ATTUNE trial of BNC210 in patients with PTSD demonstrating that the trial met its primary endpoint and several secondary endpoints, and that BNC210 was generally well tolerated. The full data analysis is detailed below and in an accompanying presentation of the results that is posted on the Company’s website. “The full results of the ATTUNE Phase 2b trial further strengthen, the already compelling, topline results and position BNC210 as a potential highly differentiated treatment with rapid onset and durable efficacy that could improve outcomes for patients with PTSD. There are over 13 million Americans adults suffering from PTSD, yet only 20%-30% of them are effectively treated with the currently approved selective serotonin reuptake inhibitors (SSRIs), which not only have slow onset of action but are also associated with many side effects,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “BNC210 is the only non-psychedelic experimental therapeutic with a novel mechanism of action that has generated evidence of a clinically meaningful improvement in PTSD total symptom severity, with a favorable effect size compared to approved treatments, and a favorable safety and to...