Index Pharmaceuticals announced positive topline data from the phase 2b CONDUCT study of cobitolimod for the treatment of moderate to severe ulcerative colitis.

Cobitolimod is a first in class, toll-like receptor 9 (TLR9) agonist with local anti-inflammatory effects in the large intestine, which may promote mucosal healing. It also has limited systemic absorption that allows for a favorable safety profile.

CONDUCT is a randomized, double-blind, placebo-controlled, exploratory 12-week study that evaluated the efficacy and safety of cobitolimod in 213 adult patients with left-sided moderate to severe active ulcerative colitis. Patients were randomized to receive four doses of cobitolimod: 31mg, 125mg, or 250mg on 2 occasions, or 125mg on 4 occasions, or placebo. The primary end point was the induction of clinical remission at week 6 defined by modified Mayo sub scores, with a rectal bleeding score of 0, stool frequency score of 0 or 1, and endoscopy score of 0 or 1.

Results showed a significantly superior efficacy in clinical remission at week 6 for patients treated with cobitolimod 250mg administered on 2 occasions compared to placebo (P =.0495, OR=3.8). A comparison of the 4 treatment arms demonstrated the following observed proportions of patients in clinical remission: 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 31mg x 2; compared to 6.8% for placebo.

The Company indicated that complete results will be published in a scientific journal and presented at upcoming medical conferences.

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“We are very pleased that the CONDUCT study achieved its primary objective to identify the most efficacious dosing regimen,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “We will now advance cobitolimod towards phase 3 and in parallel, evaluate the best route to commercialization.”

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