Wednesday, August 25, 2021
InDex Pharmaceuticals Holding AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has given clearance to start the phase III clinical study CONCLUDE in the United States. The study will evaluate the efficacy and safety of the first-in-class TLR9 agonist cobitolimod for the treatment of moderate to severe left-sided ulcerative colitis.
"The United States is the largest pharmaceutical market in the world, and to receive clearance from the FDA to start the phase III study CONCLUDE with cobitolimod is an important milestone for InDex," said Peter Zerhouni, CEO of InDex Pharmaceuticals.
CONCLUDE is a global phase III study that will be conducted at several hundred clinics in over 30 countries. The process of applying for and obtaining approval from the relevant authorities in the participating countries is ongoing. It is a randomised, double-blind, placebo-controlled, clinical study to evaluate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis.
The induction study will include approximately 440 patients, and the primary endpoint will be clinical remission at week 6. Apart from the dosing 250 mg x 2, which was the highest dose and the one that showed the best efficacy in the phase IIb study CONDUCT, the phase III study will also evaluate a higher dose, 500 mg x 2, in an adaptive study design. Patients responding to cobitolimod in the induction study will be eligible to continue in a one-year maintenance study, where they will be treated with either cobitolimod or placebo.