Bionomics (ASX:BNO) has announced positive topline results from its Phase 2b ATTUNE trial of BNC210 for the treatment of Post-Traumatic Stress Disorder (PTSD).
The Australian company is developing novel, first-in-class, allosteric ion channel modulators to treat patients with serious central nervous system (CNS) disorders.
ATTUNE is a double-blind, placebo-controlled Phase 2b trial conducted in a total of 34 sites in the US and the UK, with 212 enrolled patients, randomised 1:1 to receive either twice daily 900 mg BNC210 as a monotherapy or placebo for 12 weeks.
The company said the trial met its primary endpoint of change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score from baseline to week 12. It said a statistically significant change in CAPS-5 score was also observed at weeks four and eight.
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, said the company. The secondary endpoints were improvements in depressive symptoms and insomnia.
“We are excited about the results of the ATTUNE trial that delivered a positive dataset with treatment effects considerably higher than currently approved therapies. We believe these results will enable FDA discussions for the registrational path of BNC210 in PTSD, which in an indication with high unmet need,” said Spyros Papapetropoulos, President and CEO of Bionomics. “I am thankful to the patients, their families, and the clinical teams who participated and contributed to this study. These results, together with the results from earlier this year in social anxiety disorder, and the recently completed Phase 3-enabling End-of-Phase 2 meeting with the FDA on social anxiety disorder, positions BNC210 as a compelling late-stage experimental therapeutic for multiple prevalent neuropsychiatric diseases with high unmet need.”
The company added that it recently held what it believes was a successful, Phase 3-enabling End-of-Phase 2 meeting with the US 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.