Celgene’s Otezla better than placebo in a phase 2 test
February 15, 2018Celgene Corporation said that a higher proportion of patients taking apremilast 30 mg twice daily (BID) achieved clinical remission versus placebo. Otezla (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4).
The company will present that data from a randomized, placebo-controlled, multi-center, phase II clinical trial of apremilast in patients with active ulcerative colitis who had failed at least one conventional therapy but were naïve to biologic therapy 13th Congress of ECCO in Vienna on Thursday.
Presenting author Silvio Danese, Head of the Inflammatory Bowel Disease Clinical and Research Center, Humanitas Research Hospital, said. “The achievement of clinical remission, which requires endoscopic improvement of the mucosa, is a meaningful goal in the treatment of ulcerative colitis. These findings suggest apremilast, which improved the likelihood of achieving remission in this 12-week study, merits further study in a larger trial.”
“The strength of these data advances our plans to initiate a phase III program for Otezla (apremilast) 30 mg in ulcerative colitis,” said Terrie Curran, President, Celgene Inflammation and Immunology. “We remain committed to bringing forth innovative, oral, immunomodulatory treatment options for patients with inflammatory bowel disease.”