BioCity Biopharma's SC0062 Achieves Primary Endpoint in Phase 2 CKD Trial, Demonstrates Significant Proteinuria Reduction

09 July 2024 | Tuesday | News

SC0062, a Novel ETA Selective Antagonist, Shows Promising Efficacy and Safety in the 2-SUCCEED Trial for Chronic Kidney Disease, Including Favorable Results in Combination with SGLT2 Inhibitors
Image Source : Public Domain

Image Source : Public Domain

BioCity Biopharma (BioCity) announced its endothelin receptor type A (ETA) selective antagonist SC0062 met the primary endpoint of proteinuria reduction in the 2-SUCCEED trial: a randomized, double-blind, placebo-controlled, dose-ranging phase 2 clinical trial of SC0062 in chronic kidney disease (CKD). The study is ongoing in the diabetic kidney disease (DKD) cohort.

  • SC0062 resulted in a clinically meaningful and statistically significant reduction in proteinuria with a clear dose-response relationship and good safety profile. 
  • No fluid retention was observed in SC0062-treated patients.  Additionally, for patients who were on SGLT2 inhibitors in the trial, the combination of SC0062 and SGLT2 inhibitors had a favorable safety profile. 

The trial data will be submitted to upcoming scientific conferences for presentation.   

SC0062 is a novel, highly selective endothelin receptor A (ETA) antagonist designed for CKD that improves renal blood flow, reduces proteinuria, and attenuates inflammatory and fibrotic processes.

SC0062 has been designed and developed with the goal of ensuring efficacy while further enhancing safety, such as mitigating the adverse effects of fluid retention, an adverse event associated with non or low selective ET antagonists due to undesirable endothelin receptor B (ETB) blockade.

Dr. Hiddo Lambers Heerspink, a world-renowned expert in clinical trials in chronic kidney disease (CKD), stated after reviewing the results that:"The SC0062 data are quite exciting, particularly the clear dose response relationship, the strong effects on proteinuria reduction, and the lack of peripheral edema related side effects.  I look forward to collaborating with BioCity on the further development of SC0062 in order to make this new selective endothelin receptor antagonist available to patients with CKD."

Dr. Ivy Wang, the Co-founder, CSO and EVP of BioCity, stated:"In recent years, several studies have reported that increasing the selectivity of a molecule for the ETA can reduce adverse effects such as sodium retention caused by its blockade of the ETB and is expected to further improve therapeutic efficacy.

SC0062 is such a novel molecule with a unique high selectivity for the ETA, and we are very pleased to see its outstanding performance in terms of safety and efficacy in the 2-SUCCEED study, which validates the molecular design hypothesis of SC0062.

Our commitment is to provide global CKD patients with a safer, more effective, and long-term use of reliable therapeutic solutions, this outcome is a great encouragement to the our team and strengthens our confidence in continuing to advance this project for benefit of patients around the world."

Dr. Yong Jiang Hei, CEO of BioCity, stated:" I am delighted and excited to share the positive news on the clinical trial outcome for SC0062, which could become an important treatment for patients with CDK, in which there is a large unmet medical need.  

Enrollment in the DKD cohort of the same study has completed, the positive feedback of the trial gives us confidence of the outcome in this cohort.   

These results represent a milestone for BioCity and signify breakthroughs not only in the development of SC0062 but for those individuals afflicted with chronic kidney disease.

Looking forward, BioCity will continue to leverage its strong clinical development capabilities to accelerate the SC0062 program, of which the next steps are a global phase III trial and ultimately global regulatory approval of SC0062 for CKD patients worldwide."


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