Curacle to Present Phase 2b Results for Diabetic Nephropathy Drug CU01 at International Conference

[Financial News] Curacle will present the Phase 2b clinical trial results for CU01, which it is developing as a treatment for kidney disease caused by diabetes, at an international academic conference.
Curacle said on the 6th that it will give an oral presentation on the Phase 2b results for CU01 in diabetic nephropathy at the 16th International Congress of Diabetes (ICDM 2026), to be held in Seoul from the 15th to the 17th.
Professor Won Gyu-jang of the Division of Endocrinology and Metabolism at Yeungnam University Medical Center will give the presentation on the 15th in a session titled “Next-Generation Technologies and Treatments Targeting the Progression of Diabetic Kidney and Liver Disease.”
CU01 is an oral treatment for kidney disease that uses dimethyl fumarate (DMF), a drug that has been used to treat multiple sclerosis and other conditions. Curacle is developing a treatment for diabetic nephropathy through “drug repurposing”—developing an existing drug to treat a different disease.
In the Phase 2b trial, conducted at 24 university hospitals in South Korea among 240 patients with diabetic nephropathy, uACR—a measure of protein levels in urine—fell by 21.45% and 22.21% in the groups receiving CU01 at 240 mg and 360 mg, respectively, compared with the placebo group. The reductions were statistically significant at both doses.
In particular, among patients whose proteinuria had not fallen sufficiently despite treatment with existing RAAS and SGLT-2 inhibitors, adding CU01 reduced uACR by up to 35.20% compared with placebo. eGFR, an indicator of kidney function, also showed a pattern of remaining at baseline levels over 24 weeks, and safety and tolerability were confirmed.
The results were first presented last June at the American Diabetes Association (ADA 2026). Based on the clinical trial results, Curacle is filing patents for new uses in South Korea, the United States, China, Japan and other countries, while refining its strategy for follow-up trials and regulatory approval.
[email protected] Sang-hee Jeong Reporter