Celgene's Crohn's Disease Drug Positive In Phase Ib Study

Celgene Corporation (NASDAQ:CELG) announced positive interim top-line results from a phase Ib trial on its investigational pipeline candidate, GED-0301 (mongersen).|

The candidate is being developed for the treatment of patients suffering from Crohn's disease (chronic inflammatory condition). Celgene has a license agreement with Nogra Pharma for the development of GED-0301.

CD-001 is a randomized, double-blind, multicenter, exploratory study evaluating the effect of oral GED-0301 on endoscopic and clinical outcomes in patients with active Crohn's disease. The trial enrolled 63 patients across multiple countries. Patients received 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 endoscopic improvement, and clinical response and remission at week 12 in a proportion of patients treated with oral GED-0301 across all three treatment regimens.

GED-0301 was found to be well tolerated with no new safety concerns.

Complete results are expected to be presented at an upcoming medical meeting later this year.

Crohn’s disease affects as many as 1.6 million people in U.S. every year, which translates into a huge boost for Celgene’s portfolio.

Note that Celgene has a robust pipeline across multiple diseases including hematology and oncology. Interesting candidates comprise CC-486 (phase III – high-risk myelodysplastic syndrome (MDS); phase II – non-small cell lung cancer), AG-221 (phase III – relapsed/refractory acute myeloid leukemia (AML)) and luspatercept (phase III – lower-risk MDS and beta-thalassemia).

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Zacks Rank & Key Picks

Celgene Corporation currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in medical genetics sector include ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) , Anika Therapeutics Inc. (NASDAQ:ANIK) and Cambrex Corporation (NYSE:CBM) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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