Bionomics’ BNC210 shows significant improvement in PTSD

Bionomics released the full dataset analysis from its Phase 2b ATTUNE trial in patients with post-traumatic stress disorder, or PTSD. 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 company will have discussion with the FDA in Q2 and is preparing for initiation of a registrational late-stage trial in PTSD by Q4. The primary endpoint of mean change from baseline in Clinician-Administered PTSD Scale for DSM-5 total symptom severity score was met showing that BNC210 led to a statistically significant improvement vs placebo at Week 12 with an effect size of 0.40. Additionally, statistically significant results were achieved for negative alterations in cognitions and mood at Week 4 and Week 8. BNC210 led to statistically significant improvement in secondary endpoints such as depressive symptoms and sleep, the Hamilton Anxiety Rating scale and the Sheehan Disability Scale. Overall, BNC210 continued to demonstrate a favorable safety profile for a psychoactive experimental therapeutic. No serious AEs were reported with BNC210.