Curacle "New Concept Drug for Ulcerative Colitis Treatment"... US FDA IND Approval

Curacle, a specialized company in developing new drugs for intractable vascular diseases, announced on the 23rd that it has received approval from the U.S. FDA for the clinical trial application (IND) of CU104, a new drug candidate for the treatment of Ulcerative Colitis.

Curacle is planning global clinical trials for CU104 and intends to enter multinational clinical trials in earnest after obtaining IND approvals from the U.S. FDA, followed by Europe and Korea.

CU104, which will enter Phase 2 clinical trials, demonstrated superiority over 5-ASA, the primary treatment for Ulcerative Colitis, in the DSS (Dextran Sulfate Sodium) animal model. In the DNBS (Dinitrobenzene Sulfonic Acid) animal model, it showed at least equivalent or better efficacy compared to secondary or later-line treatments currently under active development, such as JAK inhibitors and S1P receptor modulators, through comparative studies.

In experiments using the IL-10 Knockout animal model, known to well represent the characteristics of inflammatory bowel disease, commissioned to the gastroenterology research team at Severance Hospital, CU104 significantly improved the Disease Activity Index compared to the control group. The company stated that it confirmed the effect of normalizing the intestinal mucosa, expecting not only symptom improvement but also better long-term prognosis.

A Curacle representative said, "We have been preparing diligently for a long time through consultations with domestic and international clinical experts and collaboration with Seoul National University College of Pharmacy and new drug development support organizations, aiming to develop a treatment for Ulcerative Colitis," adding, "We have high expectations for entering Phase 2 clinical trials in the U.S."

They continued, "Many global pharmaceutical companies are showing interest in the Ulcerative Colitis treatment market, where existing biologics are fiercely competing, as a new concept drug targeting vascular endothelial dysfunction is emerging." Furthermore, they said, "Once clinical trials are in full swing, negotiations for technology export will proceed more rapidly."