Celgene stated Thursday that it will discontinue both the Phase III REVOLVE trial testing its investigational oral antisense therapy mongersen in Crohn's disease, as well as the SUSTAIN extension trial, on the recommendation of a data monitoring committee following a recent interim futility analysis. The company, whose shares fell as much as 6.3 percent on the news, noted that "no meaningful safety imbalances" were identified in the analysis.
Further, Celgene indicated that "at this time" it will not initiate the late-stage DEFINE study of mongersen in Crohn's disease, as it is waiting to review Phase II ulcerative colitis trial data for the drug, also known as GED-0301, in order "to determine next steps."
Celgene president Scott Smith remarked "while we are disappointed with the results of REVOLVE, we remain committed to advancing our portfolio of novel medicines for patients suffering from this disease and other inflammatory bowel disorders."
Celgene specifically cited its investigational therapy ozanimod, an oral S1P 1 and 5 receptor modulator under development for immune-inflammatory indications, including relapsing multiple sclerosis, ulcerative colitis and Crohn's disease. The company noted that a pivotal Phase III study of ozanimod in Crohn's disease will be initiated "in the next few months."
Meanwhile, Celgene said data from a mid-stage study of Otezla (apremilast) in the treatment of ulcerative colitis are anticipated by the end of the year. The drugmaker noted that if the results are positive, a late-stage ulcerative colitis programme for Otezla, which is already cleared in the US to treat plaque psoriasis and psoriatic arthritis, could be launched in 2018.
For related analysis, see ViewPoints: Celgene’s big swing and miss on mongersen ups the ante on ozanimod.
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