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
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.
"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
The closure of the phase III program is progressing according to plan and is expected to be completed before summer 2024.
*Clinical remission was defined as Mayo subscore for blood in stool =0, Mayo subscore for stool frequency ≤1 and endoscopic Mayo subscore ≤1.
Investor update
The company will hold an investor update on 28 February at 09:00. The investor update will be hosted by CEO
For more information:
Phone: +46 8 122 038 50
E-mail: jenny.sundqvist@indexpharma.com
Johan Giléus, CFO and deputy CEO
Phone: +46 8 122 038 50
E-mail: johan.gileus@indexpharma.com
Publication
This information is information that
This is an English translation of the Swedish press release. In case of discrepancies between the English translation and the Swedish press release, the Swedish press release shall prevail. Information in this press release is intended for investors.
https://news.cision.com/index-pharmaceuticals/r/index-pharmaceuticals-discontinues-the-development-of-cobitolimod,c3936015
https://mb.cision.com/Main/9612/3936015/2628927.pdf
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