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Celgene to Present Phase Ib Data on Crohn's Disease Drug

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Celgene Corporation’s (CELG - Free Report) wholly-owned subsidiary, Celgene International Sàrl, announced encouraging data from a phase Ib study on its pipeline candidate, GED-0301 (mongersen). Data will be presented at the United European Gastroenterology Week.

The randomized, double-blind, multi-center, exploratory study evaluated the effects of oral GED-0301 on both endoscopic response and clinical remission in patients with active Crohn's disease. Patients in the study were given one of the three active treatment regimens in a 12-week treatment phase – GED-0301 160 mg once daily for 12 weeks, GED-0301 160 mg once daily for eight weeks followed by four weeks of placebo, or GED-0301 160 mg once daily for four weeks followed by eight weeks of placebo.

Data showed that clinical improvement was observed as early as week 2, while the clinical response and remission rates were the highest in the 12-week treatment group at 67% and 48%, respectively, at week 12. Endoscopic improvement was seen across all treatment groups at 12 weeks. On the safety front, rates of adverse events and serious adverse events were found to be low and similar across the treatment groups. There were no new safety signals for oral GED-0301 160 mg daily reported in the study.

Meanwhile, the study is ongoing until all patients complete the observation phase. Data from the observation portion of the study are anticipated in 2017. The phase III program on the candidate is currently underway.



The latest study results are encouraging. Considering that a significant number of Crohn's disease patients do not witness remission with current therapies or suffer relapses over time, a regulatory approval for GED-0301 is expected to provide patients with a new treatment option.

Per Celgene’s press release, Crohn's disease, an immune-mediated, chronic inflammatory condition of the gastrointestinal tract, is estimated to affect three out of every 1,000 people in Europe and North America.

Currently approved treatments for Crohn's disease include AbbVie Inc.'s (ABBV - Free Report) Humira and Johnson & Johnson’s (JNJ - Free Report) Remicade among others.

Zacks Rank & a Stock to Consider

Celgene currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Incyte Corporation (INCY - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Incyte’s earnings estimates for 2016 and 2017 were up a respective 22.2% and 6.6% over the last 60 days. The company has beaten earnings estimates thrice in the last four quarters with an average surprise of 335.16%.

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