Date: 2016-09-21
Type of information: Halting of the trial
phase: 2-3
Announcement: halting of the trial
Company: Gilead Sciences (USA - CA)
Product: GS-5745
Action
mechanism: monoclonal antibody. GS-5745 is a humanized monoclonal antibody directed against matrix metalloproteinase 9 (MMP-9), with potential antineoplastic activity. Upon administration, anti-MMP-9 monoclonal antibody GS-5745 binds to MMP-9 and inhibits its enzymatic activity. This results in an inhibition of extracellular matrix protein degradation and, potentially, the inhibition of angiogenesis, tumor growth, invasion, and metastasis. MMP-9, a protein belonging to the MMP family, plays a key role in the degradation of collagens and proteoglycans.
Disease: ulcerative colitis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Digestive diseases
Country: Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Republic of Korea, Latvia, The Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Ukraine, UK, USA
Trial
details: This combined phase 2/3, double-blind, randomized, placebo-controlled, induction and maintenance study is evaluating the safety and efficacy of GS-5745 in subjects with moderately to severely active ulcerative colitis. It will consist of 3 parts: induction study (Cohort 1), and maintenance study (Cohort 2), and an extended treatment phase. (NCT02520284)
Latest
news: * On September 21, 2016, Gilead Sciences 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.
