Adelaide-based Bionomics (ASX:BNO) has announced that the RESTORE trial, a phase 2 clinical trial designed to evaluate the safety and efficacy of BNC210 for the treatment of post-traumatic stress disorder (PTSD), is fully recruited.
“Full recruitment in the RESTORE trial marks a significant achievement for Bionomics. The program is supported by earlier clinical studies examining the biological effects of BNC210 on the brain, on anxiety-induced behaviour in patients with Generalized Anxiety Disorder (GAD) and the ability to suppress panic attacks,” said Dr Deborah Rathjen, CEO and managing director of Bionomics. “We look forward to reporting topline data from this study in the second half of this year.”
The RESTORE trial is a randomised, double-blind, placebo-controlled phase 2 clinical trial designed to enrol up to 192 adult patients diagnosed with PTSD at sites across the US and Australia.
The primary endpoint is a decrease in PTSD symptoms as measured by the Clinician-Administered PTSD Scale (CAPS-5). Secondary endpoints include a decrease in symptoms of anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A) and symptoms of depression as measured by the Montgomery and Asberg Depression Rating Scale (MADRS).
BNC210 is a novel, first-in-class, negative allosteric modulator of the α7 nicotinic acetylcholine receptor.