GW Pharmaceuticals Announces Preliminary Topline Results from Phase 2a Ulcerative Colitis Trial

GW Pharmaceuticals Announces Preliminary Topline Results from Phase 2a Ulcerative Colitis Trial
GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing new therapeutics from its cannabinoid product platform and that commercialized the world’s first plant-derived cannabinoid prescription drug Sativex® for spasticity (rigid muscles), recently presented the preliminary top line results from a Phase 2a ulcerative colitis trial at their Research&Development event in New York City. The Phase 2a ulcerative colitis trial was a 10-week randomized, double-blind, placebo controlled study of the GWP42003 extract, which contains Cannabidiol (CBD) as the main cannabinoid, Tetrahyrdocannabinol (THC), and other cannabinoid and non-cannabinoid components. This study enrolled 60 adult patients with ulcerative colitis without remission from the condition, despite having been treated with a first line therapy, such as salicylates and, in some cases, immunosuppressive drugs.  The patients were randomized into two groups: 29 and 31 patients were distributed, respectively, in the active treatment group and to the placebo group. There were no death rates during the study, although in the first weeks of the study, more patients left the active treatment group than from the placebo treatment group due to some adverse events observed in both groups. For the treated group, an oral capsule of GWP42003 twice a day was given in a dose titration schedule until an upper limit dose of 250mg twice a day. The primary endpoint of this study included the percentage of patients with remission assessed by the MAYO score, i.e. Mayo Endoscopic Scoring, of 2 or less at the end of the study, and a variety of secondary parameters to evaluate if GWP42003 had a positive effect in patients under symptom control. Evaluating the intent to trea
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