Gilead Sciences has pulled the plug on a combined Phase II/III clinical study of GS-5745 testing the investigational anti-MMP9 antibody in 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, after the first 150 patients of a planned 1600-patient trial were treated for an eight-week induction.
The DMC recommended that the study be terminated early but identified no safety concerns. Gilead said it has also reviewed the data and determined “there is insufficient evidence of a treatment benefit” in the patients randomised to receive GS-5745.
Ulcerative colitis is a long-term condition that results in inflammation and ulcers of the colon and rectum, with key symptoms abdominal pain and bloody diarrhoea. The cause of the condition is not known.
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 (BMS’ Opdivo) and additional Phase II studies in moderately to severely active Crohn’s disease, rheumatoid arthritis and cystic fibrosis, which will all continue as planned.
