Celgene reports Phase II data for Otezla in UC

Celgene Corp. (NASDAQ:CELG) reported data from a Phase II trial in 170 patients with active ulcerative colitis (UC) showing that twice-daily 30 and 40 mg doses of oral Otezla apremilast (CC-10004) led to clinical remission at week 12, defined as a Total Mayo Score (TMS) of ≤2 points with no individual sub-score exceeding 1 point, in 31.6% and 21.8% of patients, respectively, vs. 13.8% of patients who received placebo (p<0.05 and p=not significant). This year, Celgene plans to start a Phase III program evaluating the twice-daily 30 mg dose of Otezla to treat UC.

On a secondary endpoint, low- and high-dose Otezla led to clinical remission at week 12 as measured by Partial Mayo Score (PMS) in 59.6% and 52.7% of patients, respectively, vs. 36.2% for placebo (p=0.0124 and p=not significant). Data were presented at the European Crohn’s and Colitis Organisation meeting in Vienna...