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Phase 2/3 trial of UC drug candidate terminated
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Gilead Sciences has terminated a phase 2/3 clinical trial of its investigational anti-MMP9 antibody, GS-5745, in patients with moderate-to-severe active ulcerative colitis, according to a press release.
The Data Monitoring Committee recommended the study’s termination after its planned interim analysis of unblinded efficacy and safety data following completion of an 8-week induction treatment period in the first 150 of 1,600 planned patients. The DMC determined the study met pre-specified criteria for futility.
While no safety concerns were noted, Gilead reviewed the same data and determined evidence of a treatment benefit was insufficient for either dose of GS-5745 evaluated in the trial.
Other ongoing trials of GS-5745 will continue as planned, including a phase 3 trial in patients with gastric cancer, a phase 2 trial in patients with gastric cancer also receiving nivolumab, and other phase 2 trials in moderate-to-severe active Crohn’s disease, rheumatoid arthritis and cystic fibrosis, according to the press release.