An independent Data Monitoring Committee (DMC) has completed the planned dose selection analysis including safety review and assessment for futility in Induction Study 1 of the phase III program CONCLUDE.

The DMC advises that cobitolimod is unlikely to meet the primary endpoint upon completion of Induction Study 1. The advice to stop the study was not based on 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. We are incredibly grateful to all the patients, investigators and study personnel for their engagement to date,” says Jenny Sundqvist, CEO of InDex Pharmaceuticals. “We will conduct a comprehensive analysis of all the study data before announcing next steps.”

The analysis

The pre-specified and independent analysis included the first 133 patients (i.e., approximately 30% of the total 440 patient enrollment in Induction Study 1) who had completed the 6-week induction study. As part of the analysis, the DMC performed a safety review and a futility assessment based on the primary endpoint clinical remission at week 6. A futility assessment is performed to stop a trial if the chance to reach a significant primary endpoint at the end of a study is too low.

Photo of Jenny Sundqvist: Index Pharmaceuticals