Feb. 25, 2024 -- BioCity Biopharma is pleased to announce the completion of enrollment of all 120 participants in the IgA nephropathy (IgAN) cohort in a randomized, double-blind, placebo-controlled Phase 2 clinical study of the novel, oral endothelin A (ETA)-receptor selective antagonist SC0062, currently under development for chronic kidney disease (CKD), including IgAN and diabetic kidney disease (DKD). The enrollment of DKD cohort is ongoing with expected completion by the end of Q2 2024.

"We appreciate the dedication of our colleagues and collaborators. The IgAN cohort enrollment was initiated in June 2023, and we enrolled all 120 subjects in less than 9 months. Thanks to the investigators, their teams, patients, and related BioCity colleagues", Dr. Ivy Wang, co-founder and executive vice president of BioCity, stated.

This accomplishment highlights BioCity's ability to coordinate resources and operate efficiently in clinical trials, and further solidifies its leading position in the field of CKD. Dr. Wang emphasized that this achievement aligns well with the company's strategic objectives and establishes a solid foundation for further corporate development.

Dr. Yong jiang Hei, CEO of BioCity, noted the clear trend of drug development focus on chronic diseases globally, with CKD gaining significant attention. The early entry in this field by BioCity reflects its thoughtful vision.

There are approximately 700 million potential CKD patients worldwide with 82 million in China. The vast CKD market is growing rapidly, and the unmet medical needs are significant. Proteinuria is a key prognostic indicator of disease progression in CKD and can serve as an end point to evaluate the effectiveness of interventions intended to treat CKD. Of note, the US FDA granted accelerated approval of the first treatment for IgAN using proteinuria as a surrogate clinical endpoint.

"CKD (including DKD and IgAN) with proteinuria is the primary indication under development for SC0062 which has demonstrated significant safety advantages in preclinical and Phase 1 studies. Leveraging our efficient clinical operation capabilities, we plan to accelerate the phase 2 study and initiate Phase 3 trials in 2024. Our goal is to bring this innovative medicine to patients and improve their quality of life at the earliest possible time." Dr. Hei says.

About SC0062

SC0062 is one of the most unique ETA receptor small molecule antagonists globally to enter clinical development for CKD, which designed with high selectivity for ETA receptors with the objective of ensuring efficacy while avoiding the potential safety risks associated with other molecules in the same class.

Preclinical studies have shown that SC0062 improved pathological scores in models of acute kidney injury and CKD. In the completed Phase I study, SC0062 demonstrated favorable safety profile, good tolerability, and predictable pharmacokinetic characteristics. Fluid retention, an adverse event presumable associated with ETB blockade, was not observed in the phase 1 trial in healthy volunteers.  SC0062 is potentially a best-in-class ETA receptor-selective antagonist.

About the Phase 2 Clinical Study of SC0062 (CTR20230689)

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 simultaneously at over 40 study sites nationwide.

Currently, the IgAN cohort enrollment is completed, and the DKD cohort continues to enroll patients.

Currently, BioCity Biopharma has 6 oncology assets in Phase 1 development, including the first-in-class CDH3-targeting ADC, WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and agents targeting the immune system including a T cell engager (CD3/EGFR BsAb), an immune checkpoint inhibitor (TIM-3 mAb), and a T cell activator (4-1BB mAb). In addition, an endothelin A (ETA)-receptor selective antagonist for CKD is in phase 2 clinical development.

For more information, please visit www.biocitypharma.com.