BioCity announces its endothelin receptor A selective antagonist SC0062 met the primary endpoint in IgA nephropathy in 2-SUCCEED trial: a randomized, double-blind, placebo-controlled Phase 2 trial

On July 8th, 2024, 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(ETAantagonist 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."

About Dr. Heerspink

Hiddo Lambers Heerspink is Professor of Clinical Trials and Personalized Medicine and a clinical trialist at the Department of Clinical Pharmacy and Pharmacology at the University Medical Center Groningen. Professor Lambers Heerspink’s research interests focus on optimizing current treatment strategies and finding new therapeutic approaches to halt the progression of kidney and cardiovascular diseases in patients with diabetes with a specific focus on personalized medicine.

He has successfully led and currently leads numerous clinical trials with new interventions to reduce diabetes related kidney and cardiovascular complications including the DAPA-CKD, FIND-CKD, ALIGN, ZENITH and FRONTIER trials and received in 2016 the Galien award for his research. His main expertise includes clinical trial design, personalized medicine and methodological aspects and statistical analyses of clinical trials. Professor L. Heerspink has authored and co-authored over 400 peer-reviewed publications and is editorial board member of Diabetes Obesity and Metabolism and the Clinical Journal of the American Society of Nephrology. Prof L. Heerspink serves as reviewer for and member of various committees of international professional organizations including the American Diabetes Association, and the American Society of Nephrology.

Prof Heerspink is a consultant and has received honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, CSL Behring, Chinook, Dimerix, Eli-Lilly, Janssen, Gilead, Merck, Novartis, Novo Nordisk and Travere Pharmaceuticals, and BioCity Biopharmaceuticals.

About SC0062

SC0062 is a novel and highly unique ETA antagonist due to its high selectivity for ETA over endothelin receptor B (ETB). The high ETA selectivity suggests that it has a greater potential than non-selective ET antagonists for reducing progression of CKD while avoiding the safety risks associated with other nonselective molecules in the same class.

Preclinical studies have shown that SC0062 improves pathological scores in models of acute kidney injury and CKD. In the 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 ETB blockade, was not observed in the phase 1 trial in healthy volunteers nor in the IgAN cohort of the phase 2 study.  SC0062 is potentially a best-in-class ETA selective antagonist.

The ongoing Phase 2 clinical study is designed to evaluate the efficacy and safety of SC0062 in patients with CKD with proteinuria. It is a multi-center, randomized, double-blind, placebo-controlled study with two parallel cohorts (IgAN and DKD). The trial is led by Professor Jianghua Chen, Director of the Kidney Disease Center at the First Affiliated Hospital of Zhejiang University School of Medicine and former Chairman of the Chinese Medical Association Nephrology Branch. The study is being conducted at over 40 study sites nationwide.

The 2-SUCCEED study has fully enrolled all subjects in two cohorts. The primary endpoint in the IgAN cohort was met, whereas the study is ongoing in the DKD cohort, and the results are expected in Q4 of this year.

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, BioCity’s SC0062, a highly selective ETA antagonist, is in phase 2 clinical development for CKD and a global phase 3 registration trial is being planned. In addition, BioCity has five core oncology assets in Phase 1/2 clinical development, including first-in-class CDH3-targeting ADC and GPC3-targeting ADCs, WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and a monoclonal antibody targeting TIM-3 in collaboration with AstraZeneca.

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