Bionomics has completed target enrolment of around 200 patients in its Phase IIb ATTUNE clinical trial of BNC210 for the treatment of post-traumatic stress disorder (PTSD).
The double-blind, placebo-controlled, randomised study has enrolled subjects from 27 sites in the US and seven sites in the UK.
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Subjects will be randomised into a 1:1 ratio to receive either placebo or 900mg of BNC210, given two times a day as monotherapy treatment.
Change in a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity scores from baseline to week 12 compared to placebo is the primary endpoint of the study.
The study’s secondary endpoints include change from baseline to week 12 compared to placebo on the PTSD-checklist (PCL-5).
It also includes measuring anxiety, depression, sleep and disability using various scales along with clinician and patient global impressions.
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By GlobalDataBionomics president and CEO Spyros Papapetropoulos said: “Completing enrolment in the Phase IIb ATTUNE trial paves the way for a timely topline readout and highlights our mid- and late-stage clinical development capabilities.
“Our momentum continues to grow following promising results with BNC210 in our Phase II PREVAIL study in Social Anxiety Disorder (SAD).
“Together, our SAD and PTSD programmes hold the promise of transforming the treatment paradigm in two highly prevalent neuropsychiatric disorders.”
The company is planning to announce topline results in the third quarter of this year.
