Policy & Regulation
InDex Pharmaceuticals enrols first patient in CONCLUDE pivotal phase III cobitolimod study
25 November 2021 -

InDex Pharmaceuticals Holding AB (publ), a Sweden-based pharmaceutical development company focusing on immunological diseases, announced on Wednesday that it has enrolled its first patient in the pivotal phase III study CONCLUDE.

The study is intended to assess the efficiency and safety of the first-in-class TLR9 agonist cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis.

The study is to include around 440 patients and will be carried out at several hundred clinics in more than 30 countries in Europe, the Americas and the Asia-Pacific region. The study's primary endpoint will be clinical remission at week 6, which is the same primary endpoint as used in the successful phase IIb study CONDUCT.

The medical advisors in the study are Professor William Sandborn from the University of California San Diego and Professor Walter Reinisch from the Medical University of Vienna.