GWP42003: Phase IIa data

Top-line data from 60 adults with UC who could not achieve remission on first-line treatment with salicylates in the intent-to-treat (ITT) population of a 10-week, double-blind Phase IIa trial showed that twice-daily oral GWP42003 missed the primary endpoint of improving disease remission defined as a Mayo score of =2 points at week 10 vs. placebo. GWP42003 significantly improved the proportion of patients who rated their condition as “improved” on the PGIC vs. placebo (80% vs. 55%, p=0.03). During the early weeks of the trial, 12 patients in the GWP42003 arm and 4 patients in the placebo arm withdrew from the trial. GW Pharmaceuticals said most of the withdrawals were due to minor THC-related adverse events, such as dizziness. ...