BioCity Biopharma Completes Enrollment for IgA Nephropathy Patients in Phase II Trial of SC0062
Advancing Chronic Kidney Disease Treatment
Overview
Company: BioCity Biopharma
Indication: Chronic kidney disease (CKD), IgA nephropathy (IgAN), diabetic kidney disease (DKD)
Drug: SC0062
Trial Phase: Phase 2
NCT ID: N/A
Background
Headquartered in Wuxi, China, BioCity Biopharma is steadfast in its dedication to innovating treatment for chronic kidney diseases (CKD), such as IgA nephropathy (IgAN) and diabetic kidney disease (DKD).
Key Developments
- On February 25, 2024, BioCity Biopharma announced it had completed participant enrollment for the IgAN cohort in the Phase 2 clinical trial of SC0062.
- The recruitment of all 120 subjects was achieved in less than nine months, starting in June 2023, indicating the company's efficiency.
Clinical Trial Insights
- The ongoing clinical study, conducted under the leadership of Professor Jianghua Chen, is a multi-center, double-blind, placebo-controlled evaluation of SC0062.
- It focuses on the drug's efficacy and safety in managing proteinuria, a crucial indicator of CKD progression.
- The trial is registered under the identifier CTR20230689.
Future Outlook
- Enrollment for the DKD cohort is projected to be completed by Q2 2024.
- The global burden of CKD, which affects an estimated 700 million people, underscores the importance of this research.
Preclinical and Phase 1 Findings
- SC0062, an oral endothelin A (ETA)-receptor selective antagonist, has showcased a promising safety profile in preclinical studies.
- Notably, the drug does not exhibit fluid retention issues, which are often concerns with ETB blockade.
- Phase 1 studies affirmed SC0062's tolerability and pharmacokinetic predictability.
Company's Strategic Vision
- BioCity Biopharma aims to advance SC0062 through rapid Phase 2 trials and move into Phase 3 trials in 2024.
- The company's strategy places it as a leader in CKD drug development, seeking to improve the quality of life for patients with CKD.