Curalcle Resubmits Protocol for Phase II Clinical Trial of Diabetes Nephropathy Treatment 'CU01'

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[Asia Economy Reporter Lee Gwan-joo] Curacle announced on the 26th that it has submitted the late-stage clinical trial plan for 'CU01,' a diabetic nephropathy treatment under development, to the Ministry of Food and Drug Safety.

Initially, Curacle planned to proceed directly to phase 3 using e-GFR (estimated glomerular filtration rate), which showed statistical significance in the phase 2a study, as the primary endpoint. However, based on the judgment that research on patient groups changing according to the recent U.S. diabetic nephropathy treatment guidelines is necessary, the company decided to conduct a phase 2b study with various doses and subdivided patient groups before entering phase 3.

This study focuses on confirming various indicators necessary for nephropathy treatment by adding efficacy evaluation variables such as the proportion of patients achieving a 30% reduction in uACR (urinary albumin-to-creatinine ratio), and key renal function biomarkers including Cystatin-C and TGF-β1. Additionally, efficacy and safety will be assessed at two daily doses of 240 mg and 360 mg.

Furthermore, as the predicted increase in SGLT-2i prescriptions in the future makes it important to verify combination therapy with CU01, the clinical trial was designed to confirm the therapeutic effects on diabetic kidney disease in more diverse patient groups, including those co-administered with SGLT-2i and those receiving standard treatments (ARB, ACEi).

A Curacle representative stated, “Curacle’s development strategy is to simultaneously prove the scientific excellence of the drug during the drug development process and strengthen differentiating factors from existing treatments anticipated during commercialization.” He added, “Although the change in the clinical trial plan may delay the expected launch date somewhat, it is meaningful in increasing the likelihood of clinical success and securing market competitiveness.”

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