Celgene's Data on Crohn's Disease Candidate Published - Analyst Blog

Celgene Corporation CELG announced that data from a phase II study (n = 166) on Crohn's disease candidate, GED-0301, were published in The New England Journal of Medicine. The double-blind, placebo-controlled, multicenter phase II study evaluated the use of GED-0301 in patients suffering from moderate-to-severe Crohn's disease with documented inflammatory lesions in the terminal ileum and/or right colon.

As per the newly published findings from the phase II study, the use of once daily GED-0301 40 mg (55%) or 160 mg (65%) resulted in a significantly greater proportion of patients with active Crohn's disease achieving the primary endpoint of clinical remission at both day 15 and day 28 as compared to GED-0301 10 mg (12%) or placebo (10%). Additionally, with once daily GED-0301 160 mg, 67% of patients reached glucocorticoid-free remission at day 84 as compared to 11% with placebo.

On day 15, day 28 and day 84, clinical remission rates were a respective 67%, 72% and 67% in patients treated with GED-0301 160 mg once daily; 58%, 70% and 63% in patients treated with GED-0301 40 mg once daily; 15%, 29% and 29% in patients treated with GED-0301 10 mg once daily and 21%, 14% and 21% in patients receiving placebo.

As per company sources, Crohn's disease is estimated to affect approximately 3 out of every 1,000 people in Europe and North America. Currently approved therapies for moderate-to-severe Crohn's disease includes AbbVie Inc.'s ABBV Humira.

Celgene currently carries a Zacks Rank #3 (Hold). Affymetrix Inc. AFFX and Cytokinetics, Inc. CYTK are better-ranked stocks in the health care sector, holding a Zacks Rank #1 (Strong Buy).


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