Drug News

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
  • Johan GilĂ©us, CFO and Deputy CEO

Investor Call:

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Joan David-Leonhard

Joan David Leonhard is a recent Pharm.D graduate with a strong passion for the pharmaceutical industry and a particular interest in pharmaceutical media and communication. Her brief internship experience includes roles in pharmacy where she built strong patient-pharmacist relationships and a pharmaceutical media internship where she actively contributed to drug information articles, blog posts, social media engagement, and various media projects.
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