BioCity's SC0062 Achieves Primary Endpoint in Phase 2 DKD Trial

SHANGHAI, Feb. 23, 2025 -- BioCity Biopharma has announced promising results from its Phase 2 clinical trial of SC0062, a novel endothelin receptor type A (ETA) antagonist, aimed at treating diabetic kidney disease (DKD). The trial, known as 2-SUCCEED, demonstrated that SC0062 significantly reduced proteinuria over a 12-week period in participants with DKD, achieving the primary endpoint of the study.

The randomized, double-blind, placebo-controlled trial revealed that a high dose of SC0062 (20mg) led to a substantial reduction in proteinuria compared to the placebo. This reduction was both statistically significant and clinically meaningful, marking a potential breakthrough in the treatment of DKD.

Safety evaluations in the trial showed that SC0062 maintained a favorable safety profile, with no increased risk of sodium retention relative to the placebo group. The majority of participants were concurrently receiving SGLT2 inhibitors and RAAS inhibitors as part of their standard treatment regimen. Importantly, SC0062 demonstrated strong efficacy and safety both independently and when combined with these therapies.

BioCity plans to present detailed findings, including the long-term effects of SC0062 and placebo on proteinuria after 24 weeks, at an upcoming scientific conference. The 2-SUCCEED trial is a comprehensive study designed to assess SC0062's efficacy and safety in patients with chronic kidney disease (CKD) accompanied by proteinuria. It is conducted across multiple centers and includes two distinct cohorts: IgA nephropathy (IgAN) and DKD.

Previously, SC0062 successfully met all clinical endpoints in the IgAN cohort, with results shared at the ASN Kidney Week 2024 and published in a leading nephrology journal. These promising outcomes have led to SC0062 receiving Breakthrough Therapy Designation from China's National Medical Products Administration (NMPA) for the treatment of IgA nephropathy with proteinuria. A Phase 3 trial, SUCCESS-01, is currently underway to further investigate its effectiveness for IgAN.

Dr. Ivy Wang, Co-founder and Executive President of BioCity, emphasized SC0062's potential, describing it as a "best-in-class, highly selective, small molecule ETA antagonist" that has shown both efficacy and safety in clinical studies. She highlighted the significant reduction in proteinuria and the drug's favorable safety profile in both DKD and IgAN patients as key motivators for BioCity's commitment to advancing SC0062's development for global CKD treatment.

SC0062 distinguishes itself as a selective ETA antagonist, offering advantages over non-selective endothelin receptor antagonists by potentially slowing CKD progression without the side effects associated with broader medications. Preclinical studies of SC0062 have demonstrated improved outcomes in models of acute kidney injury and CKD. Additionally, a completed Phase I study confirmed its safety, tolerability, and favorable pharmacokinetic properties.

Notably, the common adverse event of fluid retention linked to non-selective ET antagonists did not occur in SC0062's trials. BioCity is focused on developing SC0062 for IgAN, DKD, and other CKD forms as a potentially leading ETA selective antagonist.

Founded in December 2017, BioCity Biopharma is a clinical-stage company dedicated to creating innovative therapeutics for cancer and autoimmune diseases, including CKD. Their diverse pipeline includes over 10 drug candidates, ranging from small molecules to antibody-drug conjugates. Currently, BioCity is advancing SC0062 through a Phase 3 confirmatory trial for IgAN in China, with plans for a multi-regional clinical trial. Additionally, BioCity is developing five oncology assets, including novel antibody-drug conjugates and inhibitors targeting the DNA damage response pathway.