BioCity Biopharma Receives Breakthrough therapy Designation for SC0062
Friday, September 27, 2024
BioCity Biopharma has announced that its selective endothelin receptor type A (ETA) antagonist, SC0062, has been granted breakthrough therapy designation by the national medical products administration for treating IgA nephropathy (IgAN) with proteinuria.
SC0062 stands out due to its high specificity for ETA over endothelin receptor B (ETB), distinguishing it from non-selective ET antagonists. This selectivity enhances its potential to slow the progression of chronic kidney disease (CKD) while minimizing the safety concerns linked to non-selective molecules in the same class.
Preclinical research has shown that SC0062 improves pathological outcomes in models of acute kidney injury and CKD. In a completed Phase I study, SC0062 demonstrated a strong safety profile, good tolerability, and predictable pharmacokinetic behavior.
Notably, fluid retention, a common adverse effect of non-selective ET antagonists due to undesirable ETB blockade, was not observed in either the healthy volunteer group or the IgAN cohort of the Phase 2 trial. This positions SC0062 as a potentially best-in-class ETA-selective antagonist.
Currently, the Phase 2 clinical study aims to evaluate the efficacy and safety of SC0062 in CKD patients with proteinuria. This multi-center, randomized, double-blind, placebo-controlled trial includes two parallel cohorts (IgAN and diabetic kidney disease, or DKD).
SC0062 treatment has led to a clinically meaningful and statistically significant reduction in proteinuria in IgAN patients, demonstrating a clear dose-response relationship and a favorable safety profile. The incidence of peripheral edema in SC0062-treated patients was lower compared to those in the placebo group.
Furthermore, in patients receiving concurrent treatment with SGLT2 inhibitors, the combination of SC0062 and SGLT2 inhibitors showed a positive safety profile.
Source: prnasia.com
