InDex Pharmaceuticals Holding AB (publ) announced that the company will discontinue development of their drug candidate cobitolimod. Thorough analysis of the data from Induction Study 1 of the phase III program CONCLUDE has not provided any results justifying continued development. Induction Study 1 of the phase III program CONCLUDE, 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 DMC had performed a pre-specified and independent analysis including 130 patients who had completed the 6-week induction study. A futility assessment showed that cobitolimod was unlikely to meet the primary endpoint upon completion of Induction Study 1. A thorough analysis of the data, including relevant subgroup analyses, has now been completed and the results do not support continued development of cobitolimod. The primary endpoint, clinical remission at week 6 was achieved by 4.9% (2 out of 41) of the patients in the 250 mg 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. The closure of the phase III program is progressing according to plan and is expected to be completed before summer 2024.