Curacle Submits IND for Ulcerative Colitis Treatment 'CU104' Phase 2a to FDA

Curacle announced on the 22nd that it has submitted the clinical trial application (IND) for the Phase 2a clinical trial of ‘CU104,’ a new drug candidate for the treatment of ulcerative colitis (UC), to the U.S. Food and Drug Administration (FDA).

This clinical trial will be conducted to evaluate the efficacy and safety of CU104 in 45 patients with moderate to severe UC over 8 weeks, using a randomized, double-blind, placebo-controlled design. The primary efficacy endpoint is the proportion (%) of patients achieving clinical remission at week 8, and other efficacy endpoints include changes in the Mayo Score from baseline and changes in histological assessments.

UC is a chronic inflammatory bowel disease (IBD) of unknown cause, characterized by frequent episodes of loose stools or diarrhea containing blood and mucus, severe abdominal pain, and dehydration. According to global data reports, the UC treatment market size in the eight major developed countries was 7 trillion KRW in 2019 and is expected to grow at an average annual rate of 6%, reaching 12 trillion KRW by 2030.

In particular, it is explained that if the efficacy of the treatment for ulcerative colitis is verified, expansion of indications to another IBD, Crohn’s disease, is also expected. Crohn’s disease is a chronic inflammatory bowel disease that can occur throughout the digestive tract from the mouth to the anus. According to global data, the global treatment market is predicted to grow to 24 trillion KRW by 2029.

A Curacle representative stated, “UC is a market with a high unmet medical need for innovative oral treatments,” adding, “Because competition is fierce and drug development is challenging, we have made thorough preparations.”

This content was produced with the assistance of AI translation services.