Phase III setback scuttles InDex Pharma ulcerative colitis drug

22 Nov 2023
firstwordpharma.com
Phase 2Phase 3Clinical Result
InDex Pharmaceuticals said Tuesday that it will discontinue the Phase III programme for its ulcerative colitis treatment cobitolimod following a planned futility assessment. According to the company, an independent data monitoring committee (DMC) determined that cobitolimod was "unlikely to meet the primary endpoint" upon completion of Induction Study 1 of the CONCLUDE programme, and recommended that the trial be stopped.
The analysis included the first 133 patients who had completed the six-week induction study. The group accounted for roughly 30% of the total 440 participants enrolled. The DMC conducted a safety review and futility assessment based on the primary endpoint of clinical remission at week six.
"This surprising and disappointing news confirms the complexity of the disease and the need for further research within this field, especially as moderate-to-severe ulcerative colitis is an indication with high unmet medical need for new treatment options," said CEO Jenny Sundqvist, "We will conduct a comprehensive analysis of all the study data before announcing next steps," she added.
In 2020, the company reported data from the Phase IIb CONDUCT study, showing that the topically administered TLR9 agonist met the primary endpoint "with an outstanding combination of efficacy and safety." InDex noted that the DMC analysis did not recommend stopping the Phase III programme due to any safety concerns.
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