GS-5745: Phase II/III discontinued

Gilead discontinued a double-blind, international Phase II/III trial evaluating 2 dosing regimens of 150 mg subcutaneous GS-5745 for 8 weeks after an interim analysis of 150 patients with moderately to severely active UC by an independent DMC showed that GS-5745 met pre-specified futility and efficacy criteria. Specifically, the company said there was “insufficient evidence of a treatment benefit” with either dosing regimen. No safety concerns were reported. The trial was slated to enroll 1,600 patients to receive placebo or 150 mg subcutaneous GS-5745 once weekly or every 2 weeks. ...