GW Pharma Reports Preliminary Topline Results Of Ulcerative Colitis Trial

By RTT News, October 14, 2014, 07:13:00 AM EDT

(RTTNews.com) - GW Pharmaceuticals Plc. ( GWPH ) (GWP.L) Tuesday announced preliminary topline results from a Phase 2a ulcerative colitis trial to be presented today at the company's R&D Day event in New York City.

The Phase 2a pilot trial was a 10-week randomized, double-blind, placebo controlled study of GWP42003 extract, which features Cannabidiol or CBD as the primary cannabinoid and which also contains Tetrahyrdocannabinol or THC and other cannabinoid and non-cannabinoid components.

The trial included 60 adult patients with ulcerative colitis who had not been able to gain remission from the condition, despite first line treatment with salicylates, and in some cases immunosuppressive therapy.

GWP42003 was given as a twice daily oral capsule in a dose titration regimen, with an upper target dose of 250 mg twice daily. Due to the pilot nature of the study, and the small patient population, the significance value was set at p=0.1.

The primary endpoint of this study was the percentage of participants achieving remission quantified by the MAYO score and included a range of secondary measures to determine whether GWP42003 has a positive benefit for subjects on symptom control.

The study included 60 patients, of which 29 patients were randomized to the active treatment group, and 31 to the placebo group.

During the early weeks of the study, more patients withdrew from the active treatment group than from the placebo treatment group so that the per protocol population comprised only 17 patients on GWP42003 and 27 on placebo.

Most of these withdrawals were due to minor THC-related adverse events such as dizziness. GW believes that the results for the protocol compliant population are most relevant to the assessment of efficacy.

The intent to treat population or ITT includes those patients who were only exposed to GWP42003 for a short period, and therefore had little if any opportunity to benefit.

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GW Pharma Reports Preliminary Topline Results Of Ulcerative Colitis Trial