Celgene IBD Pipeline In Question As Mongersen Crohn’s Disease Trial Ends

Celgene will stop late-stage testing of its investigative therapy mongersen for Crohn’s disease after a data monitoring committee said it would be futile to continue.

Crohn's disease
Celgene Stopped A Phase III Trial For Mongersen In Crohn's Disease • Source: Shutterstock

Celgene Corp.'s hope of becoming an inflammation and immunology leader is being threatened as it pulls the plug on two studies evaluating mongersen for the treatment Crohn's disease at the recommendation of the trial's independent data monitoring committee.

Celgene's I&I Programs

Mongersen is an oligonucleotide that decreases a protein called Smad7 that is abnormally high in Crohn's disease. High levels of Smad7 interfere with an anti-inflammatory pathway in the gut called TGF-β1, which leads to increased inflammation.

Ozanimod is a novel, selective, sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator in development for immune-inflammatory indications including relapsing multiple sclerosis, ulcerative colitis and Crohn's disease. Selective binding with S1PR1 is believed to inhibit a specific subset of activated lymphocytes from migrating to sites of inflammation. The result is a reduction of circulating T and B lymphocytes that leads to anti-inflammatory activity, according to Celgene

Widely known for its oncology therapies Revlimid (lenalidomide) and Pomalyst (pomalidomide), Celgene's foray in the inflammation and immunology segment had been drawing attention as it explored three oral drugs: Otezla (apremilast), ozanimod, and mongersen (formerly GED-0301), each with different mechanism of action in inflammatory bowel disease (see box). Celgene has been hoping to use these research efforts to establish a position in the underserved areas of Crohn's disease and ulcerative colitis

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