Stockholm-based InDex Pharmaceuticals has discontinued a phase 3 trial of its lead asset in ulcerative colitis after an independent data monitoring committee advised that the study is unlikely to meet its primary endpoint.
Induction Study 1 of the phase 3 program CONCLUDE is a randomized, double-blind, placebo-controlled study testing InDex's cobitolimod in moderate to severe left-sided ulcerative colitis. The pre-specified and independent analysis of the trial included the first 133 patients (approximately 30% of total enrollment) who had completed the 6-week induction study. As part of the analysis, the monitoring committee performed a safety review and a futility assessment based on the primary endpoint clinical remission at week 6.
Cobitolimod, a TLR9 agonist, is administered locally in the large intestine, where the substance binds to Toll-like receptor 9 (TLR9) present inside immune cells as well as on the surface of epithelial cells. The binding triggers the cells to product anti-inflammatory cytokines — agents that play an important role in reducing inflammation in the large intestine caused by UC.
Back in May, InDex signed a $10 million deal with Viatris Japan to register and commercialize cobitolimod for the Japanese market.
Following the disappointing trial news, InDex says it will announce next steps for cobitolimod once a thorough analysis of the data from Induction Study 1 is been completed.