GW Pharmaceuticals (GWPH) announced disappointing results from a phase IIa study (n=60) on GWP42003 in patients suffering from ulcerative colitis who failed to gain remission despite first-line treatment with salicylates or immunosuppressive therapy. The stock was down around 8.7% following the announcement.
The randomized, double-blind, placebo controlled study on GWP42003 failed to meet the primary endpoint of disease remission which is measured by a statistically significant Mayo score of 2 or less after 10 weeks of treatment. Of the 60 patients enrolled in the study 29 patients were randomized to the active treatment group and the rest to the placebo group.
Results from the study revealed that the Mayo score of 2 or less was achieved by 41% of the patients who took GWP42003 and 30% of the patients under placebo. This is not considered to be statistically significant. Moreover, during the early stages of the study, a greater number of patients under GWP42003 withdrew compared to those under placebo. The candidate was also not well tolerated.
The candidate, however, showed statistical significance in other secondary measures like inflammatory bowel disease questionnaire and the patient global impression of change.
We are highly disappointed with the results. GWP42003 is one of the most important pipeline candidates at GW Pharma. The candidate is also being developed for the treatment of schizophrenia and glioma.
The company is currently evaluating GWP42003 for the treatment of schizophrenia in a phase IIa study which is expected to be completed in the second half of 2015. GWP42003 is being evaluated for the treatment of glioma in a phase Ib/IIa study in comparison to GWP42002 with initial safety data expected later in the year. Similar failures pertaining to the candidate will pull down the stock further.
GW Pharma currently carries a Zacks Rank #2 (Buy). Some other stocks in the healthcare sector that are worth considering include Medivation, Inc. (MDVN), Emergent BioSolutions, Inc. (EBS) and Ligand Pharmaceuticals Inc. (LGND). All three stocks hold a Zacks Rank #1 (Strong Buy).
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