BioCity Biopharma (BioCity) announced its endothelin receptor type A (ETA) selective antagonist SC0062 has been granted the Breakthrough Therapy Designation (BTD) by National Medical Products Administration (NMPA) for the treatment of IgA nephropathy (IgAN) with proteinuria.

The BTD for SC0062 was granted based on the outstanding results in subjects with IgAN and proteinuria participating in a randomized double-blind, placebo-controlled Phase 2 trial known as 2-SUCCEED. The main objective of the 2-SUCCEED trial was to evaluate the efficacy and safety of SC0062 in individuals with two types of chronic kidney disease (CKD), IgAN and diabetic kidney disease (DKD).

Treatment of IgAN with SC0062 resulted in a clinically meaningful and statistically significant reduction in proteinuria with a clear dose-response relationship and good safety profile. Peripheral edema occurred at a much lower rate in SC0062-treated subjects compared to that in the placebo group. Additionally, for subjects who were receiving concurrent treatment with SGLT2 inhibitors, the combination of SC0062 and SGLT2 inhibitors resulted in a favorable safety profile. These results will be presented at an upcoming scientific conference. The study is still ongoing in the DKD cohort, and these results are expected in Q4 of this year.

As one of the most common primary glomerular diseases worldwide, many individuals with IgAN will progress to end-stage renal disease (ESRD) within 10 to 20 years, requiring renal dialysis or kidney transplantation. While developing novel treatments for CKD, especially IgAN, has become a global focus, there remains an unmet medical need for more effective and tolerable therapeutics that can be administered safely for many years to reduce the risk of progression to ESRD.

In recent years, several studies have demonstrated that endothelin receptor antagonists can improve renal blood flow, reduce proteinuria, and alleviate inflammatory and fibrotic processes, making them a promising therapeutic option for treating IgAN and other forms of CKD. SC0062 is a novel, highly selective ETA antagonist designed for CKD and the results from a Phase 1 study of SC0062 in healthy volunteers and subjects with IgAN in the 2-SUCCEED study have demonstrated its potential to be the "best-in-class" endothelin antagonist in the treatment of IgAN or CKD.

Currently, BioCity is planning Phase 3 clinical trials of SC0062 in China and worldwide with the objective of registering and marketing the agent in IgAN, DKD and other types of CKD.