Ulcerative Colitis IND Trial Application Cleared by FDA for InDex’s Cobitolimod

Ulcerative Colitis IND Trial Application Cleared by FDA for InDex’s Cobitolimod
The U.S. FDA has cleared InDex Pharmaceuticals AB's Investigational New Drug (IND) application to launch a Phase 2b clinical trial for cobitolimod (Kappaproct) in patients with moderate to severe ulcerative colitis (UC). Cobitolimod is the the Stockholm, Sweden-based company's lead drug candidate, now in late-stage clinical development for moderate to severe ulcerative colitis. UC is a chronic inflammation of the large intestine which can often be debilitating. Cobitolimod is a first-in-class TLR (Toll-like receptor) 9 agonist that mimics microbial DNA, the natural ligand of the receptor, through immunomodulation. The drug candidate provides local anti-inflammatory relief by healing the colonic mucosa and improving clinical symptoms. In January, the World Health Organization (WHO) recommended the International Nonproprietary Name (INN) "cobitolimod," also known as Kappaproct and DIMS0150. Cobitolimod has been successful at its clinical proof-of-concept studies in moderate to severe ulcerative colitis, with a very favorable safety profile. Data from four placebo-controlled clinical trials suggested the product has statistically significant effects on the most relevant endpoints for the disease, either from a regulatory or clinical perspective. Endpoints comprise pivotal clinical symptoms, such as existence of blood in stool, number of stools, and mucosal healing. The upcoming Phase 2b clinical trial will be a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of cobitolimod in inducing clinical remission in patients with chronic moderate to severe ulcerative colitis. The study will also assess higher dose levels and more frequent dosing than previously used in other studies, aim
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3 comments

  1. Cecilia Follens says:

    Please can I have more information.. I am from South Africa and is struggling with UC. I am on Humira, Assacol,Cortisone, Denol and still struggling….. Regards Cecilia Follens

    • Tim Bossie says:

      Cecilia, we are working hard to continue to provide the most relevant, accurate and timely information for people who suffer with UC like you. 🙂

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