Business
Bionomics Announces the Completion of Enrollment in Phase 2b ATTUNE Clinical Trial of BNC210 in Patients with Post-Traumatic Stress Disorder (PTSD)
Topline results expected in Q3 2023 ADELAIDE, Australia, April 27, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (Bionomics or
About this update from Neuphoria Therapeutics Inc.
[{"type":"text","content":"Topline results expected in Q3 2023\nADELAIDE, Australia, April 27, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (Bionomics or Company), a clinical-stage biopharmaceutical company developing novel allosteric ion channel modulators for serious central nervous system (CNS) disorders with high unmet medical need, today announced that the Company has completed target enrollment of approximately 200 participants in its randomized, double-blind, placebo-controlled, multi-center Phase 2b ATTUNE clinical trial evaluating BNC210 in Post-Traumatic Stress Disorder (PTSD). Topline results are expected in the third quarter of 2023. “2023 is on track to be a pivotal and milestone-rich year for Bionomics. Completing enrollment in the Phase 2b ATTUNE trial paves the way for a timely topline readout and highlights our mid- and late-stage clinical development capabilities. We would like to extend our continuing gratitude to trial participants, their families and to our investigators and their staff for their shared commitment to our trial and to addressing the needs of patients with CNS diseases,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “Our momentum continues to grow following promising results with BNC210 in our Phase 2 PREVAIL study in Social Anxiety Disorder (SAD). Together, our SAD and PTSD programs hold the promise of transforming the treatment paradigm in two highly prevalent neuropsychiatric disorders.” About ATTUNE ATTUNE is a Phase 2b double-blind, placebo-controlled, randomized study of 900 mg BNC210 given twice daily as monotherapy treatment for PTSD. Study participants are randomized 1:1 to receive either placebo or BNC210. Key inclusion criteria include being 18-75 years of age, having a current PTSD diagnosis with a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score of ≥ 30 at screening and baseline, and ≤ 25% decrease in CAPS-5 score from screening to baseline. The primary endpoint is change in 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), depression (Montgomery-Asberg Depression Rating Scale, MADRS), Clinician Global Impression (CGI), Patient Global ...