Gilead halts study of GS-5745 for ulcerative colitis after it fails to show efficacy
US biotech major Gilead Sciences (Nasdaq: GILD) has halted its combined Phase II/III study of investigational anti-MMP9 antibody GS-5745 for moderate to severe ulcerative colitis after it failed to demonstrate any efficacy in the first eight weeks of treatment, it has emerged.
In a statement, the company confirmed that the decision followed a planned interim analysis of unblinded efficacy and safety data by the Data Monitoring Committee (DMC) after the first 150 patients of a planned 1600-patient trial were treated for an eight-week induction duration.
The DMS recommended the study be terminated early as it had met the pre-specified futility and efficacy criteria.
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