Bionomics reports ‘positive’ results from Phase 2b ATTUNE trial of BNC210

Bionomics announced positive topline results from its Phase 2b ATTUNE trial of BNC210 for the treatment of PTSD, as described more fully below. ATTUNE is a double-blind, placebo-controlled Phase 2b trial conducted in a total of 34 sites in the United States and the United Kingdom, with 212 enrolled patients, randomized 1:1 to receive either twice daily 900 mg BNC210 as a monotherapy or placebo for 12 weeks. The trial met its primary endpoint of change in Clinician-Administered PTSD Scale for DSM-5 total symptom severity score from baseline to Week 12. A statistically significant change in CAPS-5 score was also observed at Week 4 and at Week 8. Treatment with BNC210 also showed statistically significant improvement both in clinician-administered and patient self-reporting in two of the secondary endpoints of the trial. Specifically, BNC210 led to significant improvements at Week 12 in depressive symptoms and sleep as measured by Montgomery-Asberg Depression Rating Scale and Insomnia Severity Index, respectively. BNC210 also showed signals and trends across visits in the other secondary endpoints including the clinician and patient global impression – symptom severity and the Sheehan Disability Scale. Additionally, the company recently held what it believes was a successful, Phase 3-enabling End-of-Phase 2 meeting with the FDA for the advancement of BNC210 for the acute treatment of social anxiety disorder into registrational studies and is awaiting receipt of the formal meeting minutes.