InDex Pharmaceuticals Discontinues Cobitolimod Phase III Program
Stockholm, Nov. 21, 2023 – InDex Pharmaceuticals Holding AB (publ) (“InDex Pharmaceuticals”) has announced the discontinuation of the phase III program CONCLUDE for cobitolimod. The decision comes following advice from an independent Data Monitoring Committee (DMC), which indicated that cobitolimod is unlikely to meet the primary endpoint upon completion of Induction Study 1.
The DMC completed the planned dose selection analysis, including safety review and assessment for futility in Induction Study 1. The decision to halt the study was not based on safety concerns.
Jenny Sundqvist, CEO of InDex Pharmaceuticals, expressed disappointment and acknowledged the complexity of the disease, emphasizing the high unmet medical need for new treatment options in moderate to severe ulcerative colitis. Sundqvist extended gratitude to patients, investigators, and study personnel for their engagement.
A comprehensive analysis of all study data is planned before announcing the next steps. The pre-specified and independent analysis included the first 133 patients, approximately 30% of the total 440 patient enrollment in Induction Study 1.
An investor call is scheduled for November 22 at 15:00, where further details may be provided.
Contact Information:
- Jenny Sundqvist, CEO
- 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
Investor Call:
- Date: November 22, 2023
- Time: 15:00
- Link to Investor Call
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