news

  • 26 June 2019
    InDex Pharmaceuticals enrolls last patient in phase IIb study CONDUCT with cobitolimod

    InDex Pharmaceuticals Holding AB (publ) today announced that patient enrolment was completed in the dose optimisation study CONDUCT, which is evaluating cobitolimod for the treatment of moderate to severe ulcerative colitis. Top line results are expected to be available in 8-10 weeks.

    The CONDUCT study is a randomised, double blind, placebo-controlled phase IIb study designed to evaluate the TLR9 agonist cobitolimod’s efficacy and safety in inducing clinical remission, compared to placebo, in patients with left-sided moderate to severe active ulcerative colitis who have not responded to conventional therapy. The study has enrolled a total of 213 patients at 91 clinics in 12 European countries and investigates three different dose strengths and two different dose frequencies of cobitolimod.

    “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,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “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 study objective is to identify the dosing regimen that provides the optimal efficacy, defined by FDA and EMA agreed endpoints for the indication, while maintaining the favourable safety profile seen with the compound in previous clinical studies. No safety issues have been noted in the more than 180 patients that have already completed the study.

    As per industry standards, after the last patient has undergone requisite study visits and all the data is quality controlled, the database will be locked and the study unblinded for data analysis. Top line results are expected to be available in 8-10 weeks.