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STOCKHOLM – InDex Pharmaceuticals, a biopharmaceutical company specializing in immunological diseases, has announced insufficient efficacy results from its phase III CONCLUDE study of cobitolimod, a drug candidate for the treatment of ulcerative colitis. The independent Data Monitoring Committee (DMC) conducted a safety check and futility analysis on initial patient data, examining clinical remission at week 6 for the first 133 out of the planned 440 patients.
The DMC concluded that cobitolimod is unlikely to meet the primary endpoint of achieving clinical remission in Induction Study 1 for ulcerative colitis treatment. However, no safety concerns were reported that would necessitate stopping the study due to futility. CEO Jenny Sundqvist acknowledged the complexity of addressing ulcerative colitis and emphasized the need for a thorough review of the comprehensive data before making any decisions on future actions.
InDex Pharmaceuticals will hold an investor briefing today at 15:00 CET to discuss the findings and consider next steps. The company adheres strictly to the EU Market Abuse Regulation (MAR) guidelines regarding public disclosures. It also underscores that, where there are discrepancies, its Swedish press releases should be considered authoritative over English translations.
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