A larger proportion of people treated with the highest dose of InDex Pharmaceuticals‘ investigational therapy cobitolimod achieved clinical remission compared with those treated with placebo, according to the results of a Phase 2 dose optimization study. The study met the primary endpoint of clinical remission among patients with severe-to-moderate ulcerative colitis.
Cobitolimod also was found to be well-tolerated at all doses, with no differences in the safety profile compared with placebo.
The dose optimization study, called CONDUCT (NCT03178669), was designed to evaluate the efficacy of cobitolimod at different dose levels.
A first-in-class Toll-like receptor 9 (TLR9) agonist, Cobitolimod provides an anti-inflammatory effect in the large intestine. That leads to healing of the mucosal, the outermost layer of cells in the intestine, and relief of the clinical symptoms of ulcerative colitis.
“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,” Raja Atreya, professor at the University of Erlangen-Nürnberg and principle investigator of the CONDUCT study, said in a press release.
“The significant and clinically relevant effect demonstrated with cobitolimod in this difficult to treat patient population is very encouraging,” he added.
The study included 213 people with moderate-to-severe active ulcerative colitis who were non-responsive to conventional therapy. Participants received either 30mg x2 (on two occasions), 125mg x2, 125mg x4, and 250mg x 2, of cobitolimod or placebo. Clinical remission was evaluated using the modified Mayo score.
Results indicated that there was a 15% increase in the proportion of patients that achieved clinical remission who were treated with the highest dose of cobitolimod compared with placebo.
Specifically, the proportion of patients who achieved clinical remission in the respective dose groups were 21.4% for 250mg x 2; 9.5% for the 125mg x 4; 4.7% for the 125mg x 2; 12.5% for the 30mg x 2; and 6.8% for placebo.
“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 the promising results regarding efficacy and safety of this drug, InDex plans to advance cobitolimod toward a Phase 3 clinical trial, as well as evaluate the best route to commercialization.
InDex also plans to publish the complete study results in a scientific journal and present the data at upcoming medical conferences.
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