InDex’s Cobitolimod Meets Primary Endpoint of Clinical Remission in Ulcerative Colitis Study, Results Show

InDex’s Cobitolimod Meets Primary Endpoint of Clinical Remission in Ulcerative Colitis Study, Results Show
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
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