Otezla Shows Promise in Treating Ulcerative Colitis Patients in Phase 2 Clinical Trial, Company Says

Otezla Shows Promise in Treating Ulcerative Colitis Patients in Phase 2 Clinical Trial, Company Says
Otezla (apremilast), developed by Celgene Corporation, showed promising results in a group of active ulcerative colitis (UC) patients in a Phase 2 clinical trial, the company recently announced. Participants in the randomized study included ulcerative colitis patients who had failed at least one conventional treatment but had not received any biological therapy. Otezla is an oral inhibitor of phosphodiesterase 4 (PDE4), an enzyme associated with ulcerative colitis. The therapy is thought to control the production of inflammatory agents, but the company has not determined how yet. Otezla is currently approved in the United States as a treatment for moderate-to-severe plaque psoriasis as well as for the treatment of adults with active psoriatic arthritis, but has not yet been approved for the treatment of ulcerative colitis in any country. In January 2018, the U.S. Food and Drug Administration (FDA) granted Otezla orphan drug status for the potential treatment of children with ulcerative colitis. Results from the Phase 2 trial (NCT02289417) suggest that a higher percentage of patients taking 30 mg of Otezla twice daily achieved clinical remission versus placebo in active ulcerative colitis. The company presented the data at the 13th Congress of the European Crohn's and Colitis Organization (ECCO) in Vienna, Austria. “The achievement of clinical remission, which requires endoscopic improvement of the
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