The company has announced positive results from the dose optimisation study CONDUCT, which is evaluating cobitolimod for the treatment of moderate to severe ulcerative colitis.
The study met the primary endpoint of clinical remission, demonstrating a superior efficacy of 15% (delta) in patients receiving the highest dose of cobitolimod compared to placebo. Cobitolimod was well tolerated at all dose levels and no differences in the safety profile were observed compared to placebo.
The CONDUCT study
The CONDUCT study is evaluating the first-in-class TLR9 agonist cobitolimod and includes 213 patients with left-sided moderate to severe active ulcerative colitis not responding to conventional therapy. Cobitolimod met the study’s primary endpoint with a significantly superior efficacy in clinical remission, as defined by modified Mayo score, at week 6 for the dose group receiving 250mg x 2 of cobitolimod compared to placebo (p=0.0495, OR=3.8).
“We are very pleased that the CONDUCT study achieved its primary objective to identify the most efficacious dosing regimen and also confirmed the excellent safety profile of cobitolimod observed in previous clinical studies,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “With an outstanding combination of efficacy and safety, cobitolimod is set to take a leading position within the field. We will now advance cobitolimod towards phase III and in parallel evaluate the best route to commercialisation.”
The observed proportions of patients in clinical remission in the respective dose groups were: 21.4% for the 250mg x 2; 9.5% for the 125mg x 4; 4.7% for the 125mg x 2; 12.5% for the 30mg x 2; compared to 6.8% for placebo.
”The significant and clinically relevant effect demonstrated with cobitolimod in this difficult to treat patient population is very encouraging,” said Professor Raja Atreya at the University of Erlangen-Nürnberg and principle investigator of the CONDUCT study. “Despite existing treatment options, there is a substantial proportion of patients with moderate to severe ulcerative colitis who do not respond to available therapies and for whom there is a great medical need for new treatment options. Cobitolimod with its novel and unique mechanism of action and very favourable safety profile represents new hope for these severely ill patients.”
The company plans to publish complete study results in a scientific journal and to present them at upcoming medical conferences.
Photo of Peter Zerhouni, CEO of InDex Pharmaceuticals