A new clinical trial has begun for cobitolimod, a drug to treat local colonic inflammation in ulcerative colitis patients. The CONCLUDE trial by InDex Pharmaceuticals has enrolled its first patient for this phase of the trial, which will run parallel to their international Phase III trial of the same drug, involving more than 440 subjects.
The drug works by utilizing a Toll-like receptor 9 (TLR9) agonist, which can potentially carry localized anti-inflammatory effects to the large intestine. This should help stimulate mucosal healing and relieve some of the symptoms of ulcerative colitis.
This stage of the trial will assess the systemic uptake of the drug and will enroll a minimum of six patients afflicted with moderate to severe ulcerative colitis.
When enrollment is completed, the patients will receive 500mg doses of cobitolimod given rectally. The uptake will be measured in the patients with active UC as well as those who currently respond to therapy.
The clinical research will take the form of a randomized, double-blind, placebo-controlled trial.
In other trials, such as the phase IIb CONDUCT trial, the researchers met their primary endpoint and demonstrated robust safety and efficacy in their results. This is also supported by four previous placebo-controlled trials, highlighting the safety and tolerability of the drug.
The CEO of Index pharmaceuticals, Peter Zerhouni, commented: “This likely contributes to cobitolimod’s excellent safety profile and is a significant advantage compared to the current systemically administered drugs for ulcerative colitis that can cause severe off-target effects.”
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