InDex Pharmaceuticals Holding has announced that the first patient has been enrolled in the phase III study CONCLUDE.

The study will evaluate the efficacy and safety of the TLR9 agonist cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis.

“Given cobitolimod’s outstanding combination of efficacy and safety, the annual global peak sales at a successful commercialization are estimated to have the potential to reach more than USD 1 billion.”

“I am thrilled to announce the enrolment of the first patient in the pivotal CONCLUDE study, which is an important milestone in bringing cobitolimod to the market for patients suffering from this debilitating disease,” says Peter Zerhouni, CEO of InDex Pharmaceuticals. “The phase III program will form the basis for marketing approval of cobitolimod in moderate to severe ulcerative colitis, where great importance is put on patient safety, as current treatment options are associated with serious side effects. Given cobitolimod’s outstanding combination of efficacy and safety, the annual global peak sales at a successful commercialization are estimated to have the potential to reach more than USD 1 billion.”

Read more: Interview – Peter Zerhouni, CEO, InDex Pharmaceuticals

Conducted in over 30 countries

The study will include approximately 440 patients and be conducted at several hundred clinics in over 30 countries including Europe, the Americas and the Asia-Pacific region.

Professor William Sandborn at the University of California San Diego and Professor Walter Reinisch at the Medical University of Vienna respectively are the Medical Advisors in the study.

Photo of Peter Zerhouni: Kristian Pohl