The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted BioCity's endothelin receptor type A (ETA) antagonist, SC0062, a second breakthrough therapy designation (BTD).
This new designation is intended to treat diabetic kidney disease (DKD) with albuminuria and highlights the therapy’s potential for chronic kidney disease indications.
The BTD was supported by data from the DKD cohort of the Phase II 2-SUCCEED trial, and SC0062 showed major reductions in albuminuria at the 20mg dose against placebo.
The safety profile was favourable both as monotherapy and when combined with treatments such as SGLT2 inhibitors, GLP-1 receptor agonists, RAAS inhibitors, insulin and Finerenone.
BioCity co-founder and executive president Dr Ivy Wang stated: “With over 700 million people affected globally, kidney disease represents one of our greatest unmet medical challenges.
“This dual BTD recognition validates SC0062's potential to redefine treatment paradigms across renal diseases. We're accelerating development to deliver this promising therapy to patients worldwide.”
The completed 2-SUCCEED programme achieved all efficacy and safety endpoints at 12 and 24-week timepoints for both Immunoglobulin A nephropathy (IgAN) and DKD cohorts.
SC0062 may slow CKD progression compared to non-selective treatments while minimising side effects.
Preclinical studies have shown that it significantly improved pathological scores in acute and CKD models.
The therapy has completed Phase I trials, demonstrating good tolerability, safety and pharmacokinetics without signs of fluid retention.
It has now concluded enrolment for both IgAN and DKD cohorts in the Phase II 2-SUCCEED study and the cohorts have met their primary endpoints.
With these developments underway, BioCity is initiating two Phase III clinical trials that include SUCCESS-01 (IgAN) and SUCCESS-02 (CKD).
