IgAN Cohort Fully Enrolled in SC0062 Phase II Trial

BioCity Biopharma has successfully completed the recruitment of 120 participants for the IgA nephropathy (IgAN) group in their Phase 2 clinical trial of SC0062, a novel oral medication targeting the endothelin A (ETA) receptor. This development is a significant step forward in the treatment of chronic kidney disease (CKD), which includes IgAN and diabetic kidney disease (DKD). The trial is designed to be randomized, double-blind, and placebo-controlled, and the recruitment for the DKD group is expected to be completed by the end of the second quarter of 2024.

Dr. Ivy Wang, co-founder and executive vice president of BioCity, expressed gratitude to all involved, noting that the enrollment process for the IgAN group began in June 2023 and was completed in under nine months. This milestone underscores BioCity's proficiency in conducting clinical trials and its leading role in CKD research. Dr. Wang also highlighted that this success is in line with the company's strategic goals and sets a strong foundation for its future growth.

BioCity's CEO, Dr. Yong Jiang Hei, pointed out the global trend towards developing treatments for chronic diseases, with CKD being a key area of focus. BioCity's early involvement in this field is a testament to its foresight. With an estimated 700 million potential CKD patients worldwide, including 82 million in China, the market for CKD treatments is expanding rapidly, and there is a significant need for medical solutions.

Proteinuria, a significant indicator of CKD progression, is a primary focus for the development of SC0062. The US FDA has granted accelerated approval for the first IgAN treatment using proteinuria as a clinical endpoint. SC0062 has shown significant safety advantages in preclinical and Phase 1 studies, and BioCity plans to expedite the Phase 2 study with the aim of initiating Phase 3 trials in 2024.

SC0062 is a unique small molecule antagonist of the ETA receptor, designed with high selectivity to ensure efficacy while minimizing safety risks associated with other molecules in its class. Preclinical studies have shown improvements in acute kidney injury and CKD models, and Phase 1 studies have demonstrated a favorable safety profile, good tolerability, and predictable pharmacokinetics. Notably, fluid retention, a potential adverse event associated with ETB blockade, was not observed in healthy volunteers during Phase 1.

The Phase 2 clinical study of SC0062 is being led by Professor Jianghua Chen, an expert in the field of nephrology, and is taking place at over 40 sites across the country. With the completion of the IgAN group enrollment, the focus now shifts to the ongoing recruitment for the DKD group.

Founded in 2017, BioCity is a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for cancer, autoimmune disorders, and CKD. The company's pipeline includes more than 10 drug candidates, ranging from small molecules to monoclonal and bispecific antibodies, as well as antibody-drug conjugates. BioCity Biopharma is currently developing six oncology assets in Phase 1, targeting various aspects of cancer treatment and immune response.