InDex Pharmaceuticals Holding AB (publ) announced an update in the timing of the dose selection in the ongoing phase III study CONCLUDE with the drug candidate cobitolimod. The outcome of the dose selection is expected to be available Fourth Quarter 2023. At that point in time InDex will have finalised the assessments of consequences on the overall development timeline including topline results in CONCLUDE.

The CONCLUDE study is a phase III study evaluating the first-in-class TLR9 agonist cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis. The study will include approximately 440 patients and is conducted at several hundred clinics in over 30 countries in Europe, the Americas and the Asia-Pacific region. When 30% of the patients in the study have been randomised, a dose selection will be performed in a blinded fashion to choose the best dose of either 250 or 500 mg cobitolimod.

Following the blinded dose selection, new patients entering the study will be treated with the selected dose of cobitolimod or placebo.