Breakthrough Therapy Designation (BTD) for BioCity's SC0062, a selective endothelin type A (ETA) antagonist, granted by National Medical Products Administration for IgA nephropathy (IgAN) with proteinuria

SHANGHAI, Sept. 26, 2024 /PRNewswire/ -- 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.   

About SC0062

SC0062 is a novel and highly unique ETA antagonist due to its high selectivity for ETA over endothelin receptor B (ETB). The high ETA selectivity suggests that it has a greater potential than non-selective ET antagonists for reducing progression of CKD while avoiding the safety risks associated with other nonselective molecules in the same class.

Preclinical studies have shown that SC0062 improves pathological scores in models of acute kidney injury and CKD. In the completed Phase I study, SC0062 demonstrated a favorable safety profile, good tolerability, and predictable pharmacokinetic characteristics. Fluid retention, an adverse event associated with non-selective ET antagonists due to undesirable ETB blockade, was not observed in the phase 1 trial in healthy volunteers nor in the IgAN cohort of the Phase 2 study. SC0062 is potentially a best-in-class ETA selective antagonist.

The ongoing Phase 2 clinical study is designed to evaluate the efficacy and safety of SC0062 in patients with CKD with proteinuria. It is a multi-center, randomized, double-blind, placebo-controlled study with two parallel cohorts (IgAN and DKD). The trial is led by Professor Jianghua Chen, Director of the Kidney Disease Center at the First Affiliated Hospital of Zhejiang University School of Medicine and former Chairman of the Chinese Medical Association Nephrology Branch. The study is being conducted at over 40 study sites nationwide. 

The 2-SUCCEED study has fully enrolled all subjects in two cohorts. The primary endpoint in the IgAN cohort was met and based on this result SC0062 has granted BTD from NMPA, whereas the study is ongoing in the DKD cohort, and the results are expected in Q4 of this year.

About BioCity

Founded in December 2017, BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including CKD. BioCity has established a pipeline of more than 10 innovative drug candidates, including small molecules, monoclonal and bispecific antibodies, and antibody-drug conjugates (ADC).

Currently, BioCity's SC0062, a highly selective ETA antagonist, is in Phase 2 clinical development for CKD and a global Phase 3 registration trial is being planned. In addition, BioCity has five core oncology assets in Phase 1/2 clinical development, including first-in-class CDH3-targeting ADC and GPC3-targeting ADCs, WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and a monoclonal antibody targeting TIM-3 in collaboration with AstraZeneca.

For more information, please visit www.biocitypharma.com 
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SOURCE BioCity Biopharma