BioCity Biopharma (BioCity) announced late-breaking results of the 2-SUCCEED clinical trial of SC0062, a selective endothelin receptor type A (ET_A) antagonist, for the treatment of IgA Nephropathy (IgAN). These results were presented at the Oral Abstract Session of American Society of Nephrology (ASN) Kidney Week 2024 and published simultaneously in the Journal of the American Society of Nephrology (JASN), a leading kidney journal worldwide.  

The 2-SUCCEED trial was designed as a multi-center, randomized, double-blind, placebo-controlled, two-cohort (IgAN and diabetic kidney disease [DKD]), Phase II study. The principal objective of the IgAN cohort was to evaluate the efficacy, safety, and optimal dose of SC0062 compared to placebo to determine SC0062's ability to reduce proteinuria in subjects at high risk of disease progression. The study allowed enrolment of subjects who were receiving sodium/glucose cotransporter 2 (SGLT2) inhibitors as a background therapy. Overall, 131 patients were randomized in a 1:1:1:1 ratio to 24 weeks of treatment with either SC0062 doses of 5 mg, 10 mg, or 20 mg or placebo once daily. A similar evaluation of SC0062 in the 2-SUCCEED cohort of subjects with DKD is ongoing. 

The detailed results of the clinical trial can be obtained from the manuscript entitled "The Selective Endothelin Receptor Antagonist SC0062 in IgA Nephropathy: A Randomized Double-Blind Placebo-Controlled Clinical Trial" which was published in JASN（ASN.0000000538, October 26, 2024.）.

SC0062 has been granted the Breakthrough Therapy Designation (BTD) by the Chinese regulatory agency National Medical Products Administration (NMPA) for the treatment of IgA Nephropathy with proteinuria.

Dr. Hiddo Lambers Heerspink, a world-renowned expert in clinical trials for the treatment of chronic kidney disease (CKD), who presented the results of SC0062 at ASN, commented "The significant and sustained reduction in urine protein excretion with SC0062, along with its notable safety advantages compared to other treatments, support a larger and long-term clinical trial in subjects with various types of CKD including IgA nephropathy. We look forward to the results of further studies on this drug."