WUXI, China, Feb. 25, 2024 /PRNewswire/ -- 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.

https://en.prnasia.com/releases/global/biocity-announces-enrollment-completion-of-the-iga-nephropathy-igan-cohort-in-the-randomized-placebo-controlled-phase-ii-clinical-trial-of-the-eta-receptor-antagonist-sc0062-437619.shtml