Recently, Bionomics announced that all 193 patients enrolled in the RESTORE trial, a Phase 2 clinical trial which is 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. This RESTORE trial is a randomised, double-blind, placebo-controlled Phase 2 clinical trial that enrolled adult patients who were diagnosed with PTSD at 25 sites across the United States and Australia. After this study, a decrease in PTSD symptoms as measured by the Clinician-Administered PTSD Scale (CAPS-5) was observed with 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).
Further, in addition to this PTSD clinical trial, a Phase 2 clinical trial of BNC210 is currently recruiting elderly patients with agitation in the hospital setting. It has been seen that agitated behavioural disturbance in elderly patients is a major clinical problem, occurring acutely in hospitalised patients and chronically in nursing home residents. For this, the Company will design a trial for short treatment and rapid recruitment that will evaluate the effect of BNC210 on the resolution of agitation in hospitalised elderly patients and will assess the safety and tolerability of BNC210 in this patient population. It is expected that the results of this clinical trial will be available in Q1, CY2019. It is expected that 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. After this announcement, the stock price moved up by 3.81 per cent but traded at a lower level before market close ($0.505 on 9 July 2018; 4:00 PM AEST).
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