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 treat population (ITT), which included patients that were exposed to GWP42003 for a short period and therefore had little if any opportunity to benefit from the compound. In these findings, the Patient Global Impression of Change and the total partial MAYO score change from baseline, which included stool frequency, bleeding, and clinician global impression, were statistically significant and supportive of GWP42003.
“There is a substantial unmet need for an effective treatment in patients with mild to moderate ulcerative colitis who have failed to enter remission following first line therapy or relapse whilst taking maintenance therapy. In particular, both physicians and patients recognize the importance of avoiding steroids due to their side effect profile,” stated Dr. Peter Irving from Guy’s Hospital, London, and Chief Investigator of the study, in the press release. “These results provide promising evidence that GWP42003 may produce clinically relevant improvement in the severity of ulcerative colitis compared with placebo, in patients who complete a course of treatment.”
“In patients who were able to take GWP42003 for a prolonged treatment period, these results provide good evidence for a therapeutic effect in the treatment of ulcerative colitis in patients who had previously failed to respond to first line therapy. The results support the further investigation of GWP42003 and have provided useful pointers as to how this further investigation should best be done. 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,” said Dr Stephen Wright, R&D Director at GW Pharmaceuticals.