Sweden-based InDex Pharmaceuticals has commenced patient enrolment in Phase IIb CONDUCT clinical trial of cobitolimod for the treatment of patients with ulcerative colitis.
Cobitolimod is an immunotherapeutic drug candidate being developed as a Toll-like receptor 9 (TLR9) agonist to induce the anti-inflammatory effects in the large intestine.
The CONDUCT trial is designed to recruit a total of 215 patients with left-sided moderate-to-severe active ulcerative colitis at up to 90 clinical centres across the Czech Republic, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, Sweden and Ukraine.
The randomised, double-blind, placebo-controlled, dose optimisation trial will assess the efficacy and safety of three different dose strengths and two different dose frequencies of cobitolimod in inducing clinical remission.
Doses of the drug candidate being investigated include 30mg, 125mg and 250mg twice at baseline and at the third week.
The 125mg dose strength will be studied following four times administration at baseline and each week until week three.
InDex Pharmaceuticals CEO Peter Zerhouni said: "The goal of CONDUCT, while maintaining cobitolimod's excellent safety profile, is to show a substantially higher efficacy than in previous studies, and also in comparison with what has been reported both for drugs on the market and other compounds in late-stage clinical development for moderate-to-severe active ulcerative colitis."
The trial’s primary endpoint is the induction of clinical remission at week six as measured by modified Mayo sub scores, a rectal bleeding score of zero, a stool frequency score of zero or one, and an endoscopy score of zero or one.
Being conducted in partnership with biopharmaceutical services provider Parexel, the Phase IIb trial’s top-line results are expected in the fourth quarter of next year.