Curacle Applies for Phase 2 Clinical Trial of Ulcerative Colitis New Drug... Aiming to Start in August

Curacle announced on the 21st through a public disclosure that it has submitted the clinical phase 2 trial protocol (IND) for CU104, which is being developed as a treatment for ulcerative colitis, to the Ministry of Food and Drug Safety.

Curacle CI
Photo by Curacle

CU104 is a pipeline that expands the indications of CU06, which is being developed as a blocker for vascular endothelial dysfunction diseases that cause diabetic macular edema and others. In various animal model experiments, it demonstrated superiority compared to 5-aminosalicylic acid (ASA), which is used as a first-line treatment for ulcerative colitis, and showed at least equivalent efficacy compared to second-line treatments such as Janus kinase (JAK) inhibitors and sphingosine 1-phosphate (S1P) receptor modulators. In particular, efficacy was confirmed in interleukin (IL)-10 deficient animal model experiments, which are effective models for predicting the therapeutic efficacy of the drug.

Previously, Curacle received approval for the phase 2 IND from the U.S. Food and Drug Administration (FDA) in June last year, and from regulatory agencies in three European countries?Serbia, Bosnia, and Macedonia?in December. This phase 2 clinical trial aims to compare the efficacy against placebo in clinical remission and response at week 8 in 45 patients with moderate to severe ulcerative colitis. The trial is planned to start in August and be completed by August 2026.

Meanwhile, Curacle voluntarily withdrew the phase 1b clinical trial application for CU06-1004, a high dose of CU06 being developed as a treatment for diabetic macular edema and other conditions, which was submitted to the Ministry of Food and Drug Safety in August last year. A Curacle official stated, “As a result of ongoing formulation research to enhance competitiveness, the development of an improved formulation has come into visible reach,” and added, “Once the development of the new formulation is completed, we plan to reapply for the phase 1b clinical trial using that formulation.”

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