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This phase 3 program was advised to discontinue given that cobitolimod was shown to be less likely to meet its primary endpoint.
InDex Pharmaceuticals made an announcement that there would be a discontinuation of the planned dose selection analysis for Induction Study 1 in the phase 3 program on cobitolimod titled CONCLUDE.1
There was an independent Data Monitoring Committee (DMC) that performed the analysis, which involved a safety review as well as an assessment for futility.
It is unlikely that cobitolimod will achieve the primary endpoint upon the completion of Induction Study 1, according to the DMC's recommendation.
Notably, the announcement on this decision to halt the research was noted as having not been influenced by safety concerns.
“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,” Jenny Sundqvist, CEO of InDex Pharmaceuticals, said in a statement. “We are incredibly grateful to all the patients, investigators and study personnel for their engagement to date,”
The analysis was centered around the first 133 subjects, constituting around 30% of the total 440 participant group in Induction Study 1, who had done the 6-week induction study.
As part of its pre-specified and independent evaluation, the DMC utilized a safety review and a futility assessment based upon the primary endpoint of clinical remission at the 6-week mark.
The use of a futility assessment discontinues a study provided that the likelihood of reporting a substnatial primary endpoint at the study's conclusion is deemed by the research team to be too low.
Sundqvist did explain that their team at InDex will carry out a comprehensive analysis of all the study data prior to an announcement of any next moves.