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Bionomics Completes Last Patient Last Visit in the Phase 2b ATTUNE Study for Post-Traumatic Stress Disorder (PTSD) and Confirms Expected 2023 Milestones with its Lead Asset BNC210
The last patient last visit has been completed in the Phase 2b ATTUNE study of BNC210 for the treatment of PTSDTopline results from Phase 2b ATTUNE study of
About this update from Neuphoria Therapeutics Inc.
[{"type":"text","content":"The last patient last visit has been completed in the Phase 2b ATTUNE study of BNC210 for the treatment of PTSDTopline results from Phase 2b ATTUNE study of BNC210 in patients with PTSD are expected by the end of September 2023An end-of-phase 2 (EoPh2) meeting with the U.S. Food and Drug Administration (FDA) has been scheduled for September 2023 to review results from the Phase 2 PREVAIL study in patients with Social Anxiety Disorder (SAD) and to obtain feedback on a proposed Phase 3 registrational programBionomics is scheduled to delist from the Australian Securities Exchange on 28 August 2023 ADELAIDE, Australia, and CAMBRIDGE, Mass., Aug. 23, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (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 last patient last visit has been completed in its Phase 2 ATTUNE study in PTSD, and disclosed timing of the End of Phase 2 (EoPh2) meeting to review advancing BNC210 into Phase 3 program in patients with SAD. “We continue our strong momentum with our fast track designated BNC210, with a robust clinical and regulatory milestone-rich year in both SAD and PTSD, two highly prevalent neuropsychiatric disorders with significant unmet needs,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “I would like to thank study participants, their families, our clinical site investigators and their staff and our clinical team for their contributions towards achieving completion of the ATTUNE study. We also look forward to our EoPh2 meeting with the FDA next month, where we will discuss our promising results from the PREVAIL study in SAD and the proposed Phase 3 clinical program.” The Phase 2b ATTUNE study (NCT04951076) is a double-blind, placebo-controlled, randomized study of twice daily BNC210 as monotherapy treatment for PTSD. The primary endpoint is change in a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity scores from baseline to week 12 compared to placebo. Secondary endpoints include change from baseline to week 12 compared to placebo on the PTSD-checklist (PCL-5), anxiety (Hamilton Anxiety Rating Scale, HAM-A), ...