BioCity Announces its selective Endothelin Type-A Receptor Antagonist, SC0062, Met the Primary Endpoint in Diabetic Kidney Disease (DKD) in a Phase 2 trial (2-SUCCEED)

, /PRNewswire/ -- BioCity Biopharma (BioCity) announced that its selective endothelin receptor type A (ET_A) antagonist, SC0062, met the 12-week primary endpoint of a reduction in proteinuria in the diabetic kidney disease (DKD) cohort of its randomized, double-blind, placebo-controlled Phase 2 trial (2-SUCCEED). The results of the trial are summarized below:

Efficacy: SC0062 significantly reduced proteinuria in the high-dose group (20mg) compared to the placebo group. The effect of SC0062 on proteinuria was both clinically meaningful and statistically significant.

Safety: SC0062 demonstrated a favorable safety profile in subjects with DKD, with no elevated risk of sodium retention compared to the placebo group. In this trial, most DKD subjects received SGLT2 (sodium-glucose co-transporter-2) inhibitors and RAAS (renin-angiotensin-aldosterone system) inhibitors as their background therapy. SC0062, both alone and in combination with these therapies, demonstrated excellent efficacy and safety.

The trial data, including the effects of SC0062 and placebo on proteinuria following 24 weeks of treatment, will be submitted to an upcoming scientific conference. 

The 2-SUCCEED trial is designed to evaluate the efficacy and safety of SC0062 in subjects with chronic kidney disease (CKD) with proteinuria. It is a multi-center, randomized, double-blind, placebo-controlled study with two parallel cohorts – IgA nephropathy (IgAN) and DKD. 

Previously, SC0062 met all clinical endpoints in the IgAN cohort. These data were presented at ASN Kidney Week 2024 and published in the Journal of the American Society of Nephrology.

Based on clinical outcomes observed to date, SC0062 has been granted Breakthrough Therapy Designation (BTD) by the Chinese regulatory agency, National Medical Products Administration (NMPA), for the treatment of IgA Nephropathy with proteinuria. A Phase 3 trial (SUCCESS-01) for the treatment of IgAN has begun (NCT06819826).

Dr. Ivy Wang, the Co-founder and Executive President of BioCity, stated "SC0062 is a best-in-class, highly selective, small molecule ET_A antagonist that has demonstrated efficacy and safety in pre-clinical studies, which have translated into highly favorable therapeutic index in subjects with both IgAN and DKD in a randomized, placebo-controlled clinical study.

We are pleased to that SC0062 demonstrated a significant reduction in proteinuria, as well as a favorable safety profile in subjects with DKD and IgAN, which greatly strengthens our commitment to develop SC0062 in CKD. BioCity is moving forward ahead with the development of SC0062 with the objective in registering SC0062 for those afflicted with CKD worldwide."

About SC0062

SC0062 is a novel and unique ET_A antagonist due to its high selectivity for ET_A compared to the endothelin receptor B (ET_B). Its strong selectivity for ET_A suggests that it has greater potential than non-selective endothelin receptor antagonists for slowing the progression of CKD while avoiding the side effects associated with non-selective medications in the same class used to treat IgAN and other types of CKD.

Preclinical studies have shown that SC0062 improves pathological scores in models of acute kidney injury and CKD. In a completed Phase I study, SC0062 demonstrated a favorable safety profile, good tolerability, and predictable pharmacokinetic characteristics.

Fluid retention, an adverse event associated with non-selective ET antagonists due to undesirable ET_B blockade, was not observed in the Phase 1 trial, and the risk was not increased compared to placebo in the IgAN and DKD cohort of the Phase 2 study. SC0062 is being developed by BioCity for IgAN, DKD, and other types of CKD as a potentially best-in-class ET_A selective antagonist.

In the 2-SUCCEED study, all subjects in the IgAN and DKD cohorts have completed all scheduled visits. The primary endpoint in the IgAN cohort was met and based on this, SC0062 has been granted Breakthrough Designation from NMPA. The study results in the DKD cohort are expected to be published in the second quarter of 2025.

About BioCity

Founded in December 2017, BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including CKD. BioCity has established a pipeline of more than 10 innovative drug candidates, including small molecules, monoclonal and bispecific antibodies, and antibody-drug conjugates (ADC).

Currently, SC0062 a highly selective ET_A antagonist owned by BioCity, is in development for CKD. A Phase 3 confirmatory trial for IgAN has been initiated in China and a Phase 3 multi-regional clinical trial (MRCT) is being planned. In addition, BioCity has five core novel oncology assets in clinical development, including first-in-class CDH3- and GPC3-targeting antibody drug conjugates (ADCs), WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and a monoclonal antibody targeting TIM-3.

For more information, please visit www.biocitypharma.com 
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SOURCE BioCity Biopharma