BioCity Reveals SC0062 IgA Nephropathy Trial Results at ASN Kidney Week 2024

SHANGHAI, Nov. 4, 2024 -- BioCity Biopharma (BioCity) revealed remarkable findings from the 2-SUCCEED clinical study concerning SC0062, an ETA antagonist, aimed at treating IgA Nephropathy (IgAN). These results were shared at the American Society of Nephrology (ASN) Kidney Week 2024 and published in the Journal of the American Society of Nephrology (JASN).

The 2-SUCCEED trial was meticulously structured as a multi-center, double-blind, placebo-controlled Phase II study, encompassing two patient groups: IgAN and diabetic kidney disease (DKD). This trial's primary goal for the IgAN cohort was to assess SC0062's effectiveness, safety, and optimal dosage compared to a placebo, focusing on its capacity to lower proteinuria in patients at elevated risk of disease progression. Subjects receiving sodium/glucose cotransporter 2 (SGLT2) inhibitors as part of their treatment were also included. Over 24 weeks, 131 patients were randomly assigned to receive either 5 mg, 10 mg, or 20 mg doses of SC0062 or a placebo.

The trial's significant findings include:

- Primary Endpoint Achievement: By week 12, patients on SC0062 experienced notable reductions in their 24-hour urine protein-to-creatinine ratio (UPCR), with reductions of 39.2%, 33.7%, and 48.3% for the 5 mg, 10 mg, and 20 mg doses, respectively, compared to 16.5% in the placebo group.
- Secondary Endpoint 1: At week 12, a significant percentage of subjects showed over a 30% reduction in UPCR—48.5%, 62.5%, and 71.0% for the respective SC0062 doses, versus 33.3% in the placebo group. Additionally, a 40% reduction was observed in 45.5%, 37.5%, and 64.5% of subjects in the SC0062 groups, compared to 18.2% in the placebo group. Furthermore, over 50% reduction in UPCR was achieved by 33.3%, 21.9%, and 51.6% of subjects on SC0062, compared to 12.1% in the placebo group.
- Secondary Endpoint 2: At week 24, the reductions in 24-hour UPCR were 39.5%, 46.1%, and 62.3% for the 5 mg, 10 mg, and 20 mg doses respectively, compared to 22.1% in the placebo group.
- Subgroup Analysis: SC0062 consistently reduced UPCR regardless of background therapy with SGLT2 inhibitors or initial UPCR levels.
- Renal Function: No significant early decline in estimated glomerular filtration rate (eGFR) was observed, and eGFR values remained stable over the 24-week period.
- Safety: SC0062 was well-tolerated, with lower rates of peripheral edema and fluid retention compared to placebo. Edema rates were 15% in the placebo group and 6%, 3%, and 3% in the SC0062 groups. Moreover, SC0062 did not cause weight gain or elevate NT-pro-BNP levels.

The manuscript detailing these outcomes, titled "The Selective Endothelin Receptor Antagonist SC0062 in IgA Nephropathy: A Randomized Double-Blind Placebo-Controlled Clinical Trial," is available in JASN. SC0062 has been recognized with Breakthrough Therapy Designation by the Chinese regulatory body, NMPA, for treating IgA Nephropathy with proteinuria.

Dr. Hiddo Lambers Heerspink, an esteemed figure in CKD clinical trials, highlighted the promising results of SC0062, noting its significant and sustained reduction in proteinuria and its favorable safety profile, advocating for larger and prolonged clinical trials for various CKD types.

SC0062 stands out as a novel and highly selective ETA antagonist. Its preclinical studies indicate improvement in acute kidney injury and CKD models, and Phase I trials have confirmed its safety and tolerability. The ongoing 2-SUCCEED Phase II study continues to assess SC0062's efficacy and safety in CKD patients with proteinuria, with the DKD cohort results anticipated by the end of 2024.

BioCity Biopharma, founded in 2017, focuses on developing innovative treatments for cancer and autoimmune conditions, including CKD. Their portfolio includes several groundbreaking drug candidates, with a global Phase III trial for SC0062 in preparation.