Cobitolimod for moderate-to-severe, left-sided ulcerative colitis (CONDUCT): a phase IIb dose-ranging induction trial.- InDEx Pharma and Merck KGaA

CONDUCT was a phase IIb dose optimisation study, evaluating the first-in-class TLR9 agonist cobitolimod for the treatment of moderate to severe ulcerative colitis. The study met the primary endpoint and cobitolimod demonstrated an outstanding combination of efficacy and safety. CONDUCT was a randomised and placebo-controlled clinical study that included 213 patients with left-sided moderate to severe active ulcerative colitis not responding to conventional therapy. The study was conducted at 91 sites in 12 different European countries. The patients were divided into four treatment arms receiving cobitolimod and one arm receiving placebo. The study met the primary endpoint with 21.4% of the patients in clinical remission at week 6 in the highest dose group receiving 250mg x 2 of cobitolimod, compared to 6.8% of the patients in the placebo group (p=0.0247). The results in several clinically relevant secondary endpoints also confirm the efficacy of the highest dose. Cobitolimod was well tolerated at all dose levels and no differences in the safety profile were observed compared to placebo. See-"Cobitolimod for moderate-to-severe, left-sided ulcerative colitis (CONDUCT): a phase 2b randomised, double-blind, placebo-controlled, dose-ranging induction trial"-Prof Raja Atreya, MD. Prof Laurent Peyrin-Biroulet, MD. Prof Andrii Klymenko, MD.Monica Augustyn, MD. Prof Igor Bakulin, MD.Dusan Slankamenac, MD.et al. Published:October 05, 2020DOI:https://doi.org/10.1016/S2468-1253(20)30301-0. Cobitolimod also known as Kappaproct, is currently in Phase III trials and world rights are licensed by InDex Pharma to Merck KGaA.