InDex completes patient enrolment for trial of cobitolimod

27th June 2019 (Last Updated June 27th, 2019 00:00)

InDex Pharmaceuticals has announced the completion of patient enrolment in the Phase IIb CONDUCT clinical trial of cobitolimod for the treatment of patients suffering from moderate to severe ulcerative colitis.

InDex Pharmaceuticals has announced the completion of patient enrolment in the Phase IIb CONDUCT clinical trial of cobitolimod for the treatment of patients suffering from moderate to severe ulcerative colitis.

Cobitolimod is a Toll-like receptor 9 (TLR9) agonist that can offer anti-inflammatory effects in the large intestine.

The randomised, double-blind, placebo-controlled, dose optimisation trial will assess the efficacy and safety of TLR9 agonist cobitolimod.

CONDUCT trial is investigating three different dose strengths of 30mg, 125mg, and 250mg given twice, at baseline and at week three. The trial is also investigating 125mg given four times at baseline and each week until week three.

The CONDUCT trial recruited a total of 213 patients with left-sided moderate-to-severe ulcerative colitis at up to 91 clinical centres Europe.

InDex Pharmaceuticals CEO Peter Zerhouni said: “We are pleased to have achieved this significant milestone for InDex and are looking forward to the study results by the end of the summer.

“Positive results will take us closer to our goal of making cobitolimod available to patients suffering from ulcerative colitis who today lack treatment options with a satisfactory combination of efficacy and safety. We would like to thank all patients, investigators and their clinical study teams participating in the study.”

The primary objective of the study is to identify the dosing regimen that provides the optimal efficacy, as defined by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) agreed endpoints for the indication.

The study also aims to maintain the favourable safety profile seen with the compound in earlier clinical studies.

According to the company, no safety issues were noted in more than 180 patients who have already completed the study.

The Phase IIb trial’s top-line results are expected in the next eight to ten weeks.