- Independent Data Monitoring Committee (DMC) advises that cobitolimod is unlikely to meet the primary endpoint upon completion of Induction Study 1
- More information regarding next steps will be provided once a thorough analysis of the data from Induction Study 1 has been completed
"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," said
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.
Investor call
The company will hold an investor call on 22 November at 15:00. If you wish to attend the call, please log in at: https://boxcast.tv/view/index-pharmaceuticals-prr5gaqpcydqusxe83kc
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@indepharma.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-cobitolimod-phase-iii-program,c3880280
https://mb.cision.com/Main/9612/3880280/2446013.pdf
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