October 14, 2014
By Riley McDermid, BioSpace.com Breaking News Staff
Cannabis biopharma GW Pharmaceuticals Ltd. said Tuesday that Phase II trials of its ulcerative colitis drug have fallen short of expected results but do show promise in other areas.
The British company focuses on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform. It presented data from a 10-week randomized, double-blind, placebo controlled study of GWP42003 extract, which features Cannabidiol (CBD) as the primary cannabinoid and contains Tetrahyrdocannabinol (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 250mg 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.
After collating data, GW said only 41 percent of those being treated saw remission compared to 30 percent taking the placebo. The study was also troubled by 12 patients who dropped out due “minor THC-related adverse events such as dizziness.”
However, GW said it remained upbeat about the 17 patients who reported marked progress with the disease, including a reduction in severity of symptoms.
“The results support the further investigation of GWP42003 and have provided useful pointers as to how this further investigation should best be done,” GW R&D Director Stephen Wright said in a statement. “In addition, the relatively poor tolerability of the dosage form used in this study suggests that further reductions to the THC content may be helpful.”
