GW Pharmaceuticals (GWPH +11.2%) heads north on increased volume in response to its announcement of positive top-line results in a Phase 2a clinical trial assessing Cannabidiol (CBD) in 88 schizophrenia patients who failed to respond adequately to first-line anti-psychotic medications. In the study, participants remained on their anti-psychotic treatments and were randomized to receive CBD or placebo as adjunct therapy.
Compared to placebo, patients in the CBD cohort showed a statistically significant improvement in the PANSS positive sub-scale (p=0.018), the Clinical Global Impression of Severity (p=0.04) and Clinical Global Impression of Improvement (p=0.02). CBD was also better than placebo in the area of cognition, but the results were shy of statistical significance (p=0.07). The trial was a proof-of-concept study so the endpoints were exploratory. There was no single primary efficacy endpoint.
CEO Justin Glover says, “These findings further reinforce the potential role of cannabinoids in the field of neuropsychiatric disease. We believe that the signals of efficacy demonstrated in this trial, together with a notably reassuring safety profile, provide GW with the prospect of a new and distinct cannabinoid neuropsychiatric product pipeline opportunity. Similar to our approach with Epidiolex, we believe that our future research in this area may lie within pediatric orphan neuropsychiatric indications and we intend to explore this as a focus for future trials.”