FOSTER CITY, CA, USA I September 21, 2016 I Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company is stopping its combined Phase 2/3 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 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.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
SOURCE: Gilead Sciences
Post Views: 47
FOSTER CITY, CA, USA I September 21, 2016 I Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company is stopping its combined Phase 2/3 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 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.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
SOURCE: Gilead Sciences
Post Views: 47
