Gilead Stops Phase 2/3 Study Of GS-5745 In Patients With Ulcerative Colitis

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(RTTNews.com) - Gilead Sciences, Inc. ( GILD ) said that it stopped its combined Phase 2/3 clinical study of GS-5745, an investigational anti-MMP9 antibody, among patients with moderately to severely active ulcerative colitis.

The 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 3 study of GS-5745 is ongoing in patients with gastric cancer, as well as a Phase 2 study in patients with gastric cancer in combination with nivolumab and additional Phase 2 studies in moderately to severely active Crohn's disease, rheumatoid arthritis and cystic fibrosis. These studies will continue as planned.

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This article appears in: Technology
Referenced Symbols: GILD


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