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Early Data for Celgene’s Oral Crohn’s Drug Gets Mixed Reaction

Xconomy New York — 

Celgene late Sunday provided more details on one of the more important drugs in its pipeline, a pill the Summit, NJ, company is developing for inflammatory bowel disease. Analysts on Wall Street are mixed on the clinical results.

The data, which Celgene is presenting at United European Gastroenterology Week in Vienna, Austria, are an early look at an ongoing, 63-patient Phase 1b study of GED-0301 (mongersen). The results represent the first time patients with Crohn’s (a form of IBD) on mongersen were given endoscopies to show how the drug is impacting the size of their ulcers. Previously, mongersen’s effects were measured only by the reduction of signs and symptoms of the disease.

In the study, Celgene enrolled 63 patients with moderate-to-severe Crohn’s. Some had previously been treated with at least one biologic drug—like infliximab (Remicade) or adalimumab (Humira), and others hadn’t. These patients were randomized, split into three groups, and given mongersen either once a day for 12 weeks; once a day for 8 weeks followed by four weeks on a placebo; or once a day for 4 weeks followed by 8 weeks on a placebo.

Celgene (NASDAQ: CELG) is reporting interim results after these 12 weeks of treatment. The company will follow patients for another 52 weeks off treatment to see the results, and afterwards eligible patients will be able to go back on mongersen for another 100 weeks as part of an extension study. These results, along with the larger Phase 3 trial Celgene is running, will provide the definitive answers on mongersen. But today’s endoscopy results are an early snapshot of the drug’s potential.

Last month, Celgene said that patients on the drug in the Phase 1b trial showed an endoscopic response—defined as a 25 percent improvement from the start of the study—after 12 weeks of treatment. Without giving specific numbers, Celgene said in September that “a proportion of patients” in all of the different treatment groups (as Celgene tested three different regimens of mongersen) improved, that there were remissions in each group, and that no new safety problems popped up.

On Sunday, Celgene provided more details, but still … Next Page »

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