BioCity's Renal Asset Succeeds in Mid-Stage IgA Nephropathy Study

BioCity Biopharma has revealed encouraging data from its mid-stage study of SC0062, aimed at treating IgA nephropathy (IgAN). This development marks a significant step as the selective endothelin receptor type A (ETA) antagonist heads towards Phase III clinical trials. The findings were shared at the Kidney Week conference and published in the Journal of the American Society of Nephrology.

The ongoing Phase II trial, known as 2-SUCCEED, is evaluating the effectiveness of SC0062 in two groups of patients with chronic kidney disease: those with IgAN and those with diabetic kidney disease (DKD). For the IgAN group, 131 patients were randomly assigned to receive one of three different doses of SC0062 or a placebo daily for 24 weeks.

Initial results, reported in July, indicated that the therapy achieved its primary and key secondary goals in the IgAN cohort. It significantly reduced urinary protein excretion compared to the placebo group, which is a critical marker for the progression of kidney disease.

The latest data showed promising results at the 12-week mark. Patients who received 5 mg, 10 mg, and 20 mg doses of SC0062 demonstrated reductions in the 24-hour urine protein-to-creatinine ratio (UPCR) by 39.2%, 33.7%, and 48.3%, respectively. This is compared to a 16.5% reduction in the placebo group. These reductions were maintained through the 24-week period.

Additionally, a higher proportion of patients treated with SC0062 showed more than a 30% reduction in UPCR across all dose levels. Some participants even experienced reductions of up to 40% and 50%, a significant difference compared to those on the placebo.

Subgroup analyses further strengthened these findings, indicating that SC0062 consistently reduced UPCR across all doses. This was true regardless of whether patients were using SGLT2 inhibitors or their baseline UPCR levels. Importantly, there was no sudden decline in the estimated glomerular filtration rate among patients treated with SC0062, with kidney function remaining stable throughout the 24-week treatment period.

From a safety perspective, SC0062 was well tolerated by patients, showing no increase in peripheral edema or fluid retention compared to the placebo group.

BioCity Biopharma also noted that the evaluation of SC0062 is still ongoing in the DKD cohort of the 2-SUCCEED trial, with results expected before the end of the year. This continued assessment will provide further insights into the drug’s efficacy and safety profile.