Gilead Sciences terminates Phase II/III trial of GS 5745 as a treatment for ulcerative colitis.

Gilead Sciences, Inc. has announced that the company is stopping its combined Phase II/III clinical study of GS 5745, an investigational anti-MMP9 antibody, among patients with moderately to severely active ulcerative colitis.

This decision follows 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 8-week induction duration. The DMC recommended that the study be terminated early due to meeting the pre-specified futility and efficacy criteria. No safety concerns were noted in this interim analysis. Gilead has also reviewed the data and determined that there is insufficient evidence of a treatment benefit in the group of patients randomized to receive either one of two doses of GS 5745.

Separately, a Phase III study of GS 5745 is ongoing in patients with gastric cancer, as well as a Phase II study in patients with gastric cancer in combination with nivolumab and additional Phase II studies in moderately to severely active Crohn�s disease, rheumatoid arthritis and cystic fibrosis. These studies will continue as planned.