InDex Pharmaceuticals will discontinue development of their drug candidate cobitolimod.
Thorough analysis of the data from Induction Study 1 of the phase III program CONCLUDE has not provided any results justifying continued development, states the company.
“We are very disappointed that we cannot detect a treatment benefit of cobitolimod compared to placebo, and that we have not been able to find an explanation for the lack of efficacy compared to previous studies. I again would like to express my sincere gratitude to all the patients, investigators and study personnel, as well as InDex team members for their engagement, support and hard work,” said Jenny Sundqvist, CEO of InDex Pharmaceuticals.
Jenny Sundqvist, CEO of InDex Pharmaceuticals
The results do not support continued development of cobitolimod
Induction Study 1 of the phase III program CONCLUDE, evaluating cobitolimod as a new treatment for moderate to severe left-sided ulcerative colitis, was discontinued on November 21, 2023 based on the advice from an independent Data Monitoring Committee (DMC). The DMC had performed a pre-specified and independent analysis including 130 patients who had completed the 6-week induction study. A futility assessment showed that cobitolimod was unlikely to meet the primary endpoint upon completion of Induction Study 1.
A thorough analysis of the data, including relevant subgroup analyses, has now been completed and the results do not support continued development of cobitolimod.
The primary endpoint, clinical remission* at week 6 was achieved by 4.9% (2 out of 41) of the patients in the 250 mg cobitolimod group and by 6.8% (3 out of 44) of the patients in the 500 mg cobitolimod group, compared to 6.7% (3 out of 45) of the patients in the placebo group. The lack of efficacy in cobitolimod treated patients was confirmed by the outcome in secondary endpoints and subgroup analysis. Cobitolimod was well tolerated at both dose levels and no differences in the safety profile were observed compared to placebo.
The closure of the phase III program is progressing according to plan and is expected to be completed before summer 2024.
Alternatives to maximize shareholder value
The company has also announced that it is evaluating other alternatives to maximize shareholder value. Alternatives such as merger and reverse merger are weighed against company liquidation. InDex Pharmaceuticals will not proceed with development of any of its other compounds.
Alternatives such as merger and reverse merger are weighed against company liquidation.”
A step-wise approach has been adopted to narrow down the number of options. Company liquidation is considered in parallel at every step. The evaluation is expected to be finalized by end of Q1. The outcome of the evaluation will form the basis for the Board’s recommendation to shareholders. Any decision on how to proceed will be subject to shareholder approval at a general meeting.
