BioCity Biopharma, a leading biopharmaceutical company, has announced the initiation of a Phase III clinical study for its kidney disease drug SC0062 at the Guangdong Provincial People’s Hospital, the leading institution for the study. The study, named SUCCESS-01, aims to evaluate the efficacy and safety of SC0062 capsules in patients with IgA nephropathy accompanied by proteinuria. The launch of the clinical study marks a significant step towards the commercialization of this promising kidney disease treatment.
SC0062: Best-in-Class ETA Antagonist
SC0062 is a best-in-class, highly selective endothelin receptor A (ETA) small molecule antagonist developed by BioCity Biopharma to address the high unmet clinical needs in various kidney diseases. As part of the overall clinical development plan, SUCCESS-01 is the first Phase III registration clinical trial for SC0062 targeting IgA nephropathy. The study is led by Professor Yu Xueqing, the president of the Guangdong Provincial People’s Hospital and the chair of the Asia-Pacific Society of Nephrology.
Clinical Trial Design and Objectives
SUCCESS-01 is a multicenter, randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of SC0062 capsules in patients with IgA nephropathy and proteinuria. The study’s initiation signifies that SC0062, a high-potential best-in-class drug, is one step closer to benefiting a large number of patients with chronic kidney disease.
SC0062 is among the top three ETA small molecule antagonists globally to enter clinical trials for the treatment of chronic kidney disease. The drug features a unique molecular design with high selectivity for the ETA receptor, aiming to enhance both efficacy and safety. SC0062 has been included in the list of breakthrough therapy designations by the Center for Drug Evaluation (CDE) for the treatment of IgA nephropathy.
Future Outlook
The advancement of SC0062 into Phase III clinical trials underscores BioCity Biopharma’s commitment to developing innovative treatments for chronic kidney disease. With its demonstrated potential and strategic clinical development plan, SC0062 is poised to make a significant impact on patient outcomes in IgA nephropathy. BioCity’s ongoing efforts highlight its dedication to improving the treatment landscape for patients with kidney diseases.-Fineline Info & Tech
