BioCity's SC0062 Receives Breakthrough Therapy Designation for IgA Nephropathy
核心洞察
BioCity Biopharma (搜索)'s SC0062, a selective endothelin type A (搜索) (ETA) antagonist, has been granted Breakthrough Therapy Designation (BTD) by the NMPA.
The BTD was based on positive Phase 2 trial results in IgA nephropathy (搜索) (IgAN) patients with proteinuria (搜索), demonstrating a statistically significant reduction in proteinuria.
SC0062 showed a favorable safety profile, including a lower incidence of peripheral edema, and is being advanced into Phase 3 trials for IgAN and other CKDs.
BioCity Biopharma (搜索)'s selective endothelin type A (搜索) (ETA) antagonist, SC0062, has received Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) for the treatment of IgA nephropathy (搜索) (IgAN) with proteinuria (搜索). The designation was granted based on promising results from the randomized, double-blind, placebo-controlled Phase 2 2-SUCCEED trial.
Phase 2 Trial Results
The 2-SUCCEED trial evaluated the efficacy and safety of SC0062 in patients with IgAN and diabetic kidney disease (搜索) (DKD). In the IgAN cohort, treatment with SC0062 resulted in a clinically meaningful and statistically significant reduction in proteinuria (搜索), with a clear dose-response relationship. Notably, the incidence of peripheral edema was lower in SC0062-treated subjects compared to the placebo group. The combination of SC0062 with SGLT2 inhibitors also demonstrated a favorable safety profile. Full data will be presented at an upcoming scientific conference; results from the DKD cohort are expected in Q4 of this year.
Unmet Need in IgAN
IgAN is a common primary glomerular disease that can progress to end-stage renal disease (ESRD) within 10 to 20 years, often requiring dialysis or kidney transplantation. There remains a significant unmet medical need for effective and tolerable therapies that can safely reduce the risk of progression to ESRD over many years.
SC0062: A Selective ETA Antagonist
SC0062 is a novel, highly selective ETA antagonist designed for chronic kidney disease (CKD (搜索)). Preclinical and Phase 1 studies have demonstrated a favorable safety profile, good tolerability, and predictable pharmacokinetic characteristics. The high ETA selectivity of SC0062 suggests a greater potential for reducing CKD progression while minimizing safety risks associated with non-selective ET antagonists. Fluid retention, an adverse event associated with non-selective ET antagonists due to undesirable ETB blockade, was not observed in the Phase 1 trial or in the IgAN cohort of the Phase 2 study.
Future Development
BioCity is planning Phase 3 clinical trials of SC0062 in China and worldwide, with the goal of registering and marketing the agent for IgAN, DKD, and other types of CKD (搜索). BioCity has established a pipeline of more than 10 innovative drug candidates, including small molecules, monoclonal and bispecific antibodies, and antibody-drug conjugates (ADC).