Celgene Drops GED-0301 as Crohn’s Therapy but Will Continue Testing It for Ulcerative Colitis

Celgene Drops GED-0301 as Crohn’s Therapy but Will Continue Testing It for Ulcerative Colitis
Celgene Corporation is giving up on GED-0301 as a Crohn's disease therapy, but will continue to evaluate its ability to treat ulcerative colitis. It ended its Phase 3 REVOLVE clinical trial (NCT02596893) and its SUSTAIN extension trial (NCT02641392) of GED-0301 as a potential Crohn's treatment after an independent trial monitoring board recommended the discontinuations. The board had reviewed the therapy's benefits and risks, and the implication of its recommendation was that GED-0301 failed to generate enough benefits. The review board recommendation prompted Celgene to cancel its plans for the Phase 3 DEFINE trial (NCT02974322), which was also supposed to evaluate GED-0301 as a Crohn's therapy. Celgene will continue testing GED-0301 as an ulcerative colitis therapy in a Phase 2 trial (NCT02601300) and other treatments it has developed for Crohn's. GED-0301 decreases levels of Smad7 in the gut. Excessive amounts of the protein interfere with the activity of a cytokine that immune cells release. Crimping the activity of the molecule, known as transforming growth factor beta 1 (TGF-β1), leads to inflammation. "We thank the patients and the investigators involved in the REVOLVE trial," Scott Smith, Celgene's president and chief operating officer, said in a press release. Crohn's "is a debilitating condition with few effective long-term treatment options. While we are disappointed with the results of
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