InDex Pharmaceuticals has announced the termination of a Phase III trial of its candidate cobitolimod in patients with ulcerative colitis (UC).
The Sweden-based pharmaceutical company published the update after an independent data monitoring committee advised the company that cobitolimod is unlikely to meet the primary endpoint of the study.
The randomised, placebo-controlled, double-blind Phase III study (NCT04985968) aimed to evaluate the efficacy and safety of cobitolimod, a toll-like receptor 9 (TLR9) agonist, in patients with moderate to severe active left-sided UC. The company enrolled its first patient into the trial in November 2021.
InDex is also running a parallel Phase I trial of the candidate (NCT05404074) to evaluate the clinical pharmacokinetics of the candidate in UC patients with colonic inflammation.
InDex Pharmaceuticals CEO Jenny Sundqvist said: “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.”
Sundqvist added the company will conduct a comprehensive analysis of all trial data before communicating the next steps.
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The committee evaluated safety and futility
The committee conducted a safety review and assessment for futility in the Phase III CONCLUDE programme. The pre-specified and independent analysis included the first 133 patients, which equated to 30% of the 440-patient enrolment, who had completed the six-week induction study.
The committee performed a safety review and a futility assessment based on the primary endpoint of clinical remission at week six. 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.
According to GlobalData’s Pharmaceutical Intelligence Centre, cobitolimod is not being trialled in any other indication and there are no ongoing clinical trials for the candidate.
GlobalData is the parent company of the Clinical Trials Arena.
In June 2023, InDex Pharmaceuticals entered a licence deal with Viatris Pharmaceutical for the development and commercialisation of cobitolimod in Japan. Under the agreement, InDex Pharmaceuticals will receive a $10m upfront payment from Viatris Pharmaceutical for the exclusive commercialisation rights in Japan.