SHANGHAI, July 8, 2024
/PRNewswire/ -- 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."
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.
For more information, please
visit www.biocitypharma.com
Or LinkedIn BioCity Biopharma
Contact:
BD@biocitypharma.com
IR@biocitypharma.com
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