InDex Pharma considers future as it drops development of cobitolimod

Swedish immunology company InDex Pharmaceuticals (STO: INDEX) late yesterday announced that the development of cobitolimod is discontinued after a thorough analysis of the data from the Induction Study 1 of the Phase III program CONCLUDE has not provided any results justifying continued development.

This study evaluating cobitolimod as a new treatment for moderate to severe left-sided ulcerative colitis, was discontinued on November 21, 2023 based on the advice from an independent Data Monitoring Committee (DMC).

The primary endpoint, clinical remission at week 6 was achieved by 4.9% (two out of 41) of the patients in the 250 g cobitolimod group and by 6.8% (3 out of 44) of the patients in the 500 mg cobitolimod group, compared to 6.7% (3 out of 45) of the patients in the placebo group. The lack of efficacy in cobitolimod treated patients was confirmed by the outcome in secondary endpoints and subgroup analysis. Cobitolimod was well tolerated at both dose levels and no differences in the safety profile were observed compared to placebo.