Australian biopharmaceutical company Bionomics (ASX:BNO) has announced that all 193 patients enrolled in the RESTORE trial, a phase 2 clinical trial designed to evaluate the safety and efficacy of its’ therapeutic candidate BNC210 for the treatment of Posttraumatic Stress Disorder (PTSD), have completed their treatment phase of the study.
BNC210 is a novel, first-in-class, negative allosteric modulator of the alpha 7 nicotinic acetylcholine receptor.
The RESTORE trial is a randomised, double-blind, placebo-controlled Phase 2 clinical trial enrolling adult patients diagnosed with PTSD at 25 sites across the United States and Australia.
The primary endpoint of this study 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 has the potential to be an innovative treatment for patients with PTSD with a solid foundation of clinical data supportive of development not only in PTSD but also in anxiety disorders and conditions where there is co-morbid anxiety and depression,” said Dr Deborah Rathjen, CEO and managing director of Bionomics.
“We are grateful to the patients and the medical community who participated in this trial.”
Another phase 2 clinical trial of BNC210 is currently recruiting elderly patients with agitation in the hospital setting.
Agitated behavioural disturbance in elderly patients is a major clinical problem, occurring acutely in hospitalised patients and chronically in nursing home residents, said the company.
The trial, designed for short treatment and rapid recruitment, will evaluate the effect of BNC210 on the resolution of agitation in hospitalised elderly patients and assess the safety and tolerability of BNC210 in this patient population.
According to the company, it will recruit approximately 40 elderly patients in specialist geriatric hospital wards across Australia. It is a randomised, double-blind, placebo-controlled design with a 5-day treatment period.