2 weeks Ago By [email protected] (MENAFN)
( MENAFN - PR Newswire) SHANGHAI, Nov. 4, 2024 /PRNewswire/ -- BioCity Biopharma (BioCity) announced late-breaking results of the 2-SUCCEED clinical trial of SC0062, a selective endothelin receptor type A (ETA) antagonist, for the treatment of IgA Nephropathy (IgAN). These results were presented at the Oral Abstract Session of American Society of Nephrology (ASN) Kidney Week 2024 and published simultaneously in the Journal of the American Society of Nephrology (JASN), a leading kidney journal worldwide.
The 2-SUCCEED trial was designed as a multi-center, randomized, double-blind, placebo-controlled, two-cohort (IgAN and diabetic kidney disease [DKD]), Phase II study. The principal objective of the IgAN cohort was to evaluate the efficacy, safety, and optimal dose of SC0062 compared to placebo to determine SC0062's ability to reduce proteinuria in subjects at high risk of disease progression. The study allowed enrolment of subjects who were receiving sodium/glucose cotransporter 2 (SGLT2) inhibitors as a background therapy.
Overall, 131 patients were randomized in a 1:1:1:1 ratio to 24 weeks of treatment with either SC0062 doses of 5 mg, 10 mg, or 20 mg or placebo once daily. A similar evaluation of SC0062 in the 2-SUCCEED cohort of subjects with DKD is ongoing. Key 2-SUCCEED Study Results Presented at ASN: The detailed results of the clinical trial can be obtained from the manuscript entitled "The Selective Endothelin Receptor Antagonist SC0062 in IgA Nephropathy: A Randomized Double-Blind Placebo-Controlled Clinical Trial" which was published in JASN(ASN.
0000000538, October 26, 2024.). SC0062 has been granted the Breakthrough Therapy Designation (BTD) by the Chinese regulatory agency National Medical Products Administration (NMPA) for the treatment of IgA Nephropathy with proteinuria.
Dr. Hiddo Lambers Heerspink, a world-renowned expert in clinical trials for the treatment of chronic kidney disease (CKD), who presented the results of SC0062 at ASN, commented "The significant and sustained reduction in urine protein excretion with SC0062, along with its notable safety advantages compared to other treatments, support a larger and long-term clinical trial in subjects with various types of CKD including IgA nephropathy. We look forward to the results of further studies on this drug.
" About SC0062 SC0062 is a novel and unique ETA antagonist due to its high selectivity for ETA over endothelin receptor B (ETB). Its extraordinary selectivity for ETA suggests that it has a greater potential than non-selective ET antagonists for reducing progression of CKD while avoiding the side effects associated with nonselective medications in the same class for 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 ETB blockade, was not observed in the phase 1 trial and the risk was not increased compared to placebo in the IgAN 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 ETA selective antagonist.
The ongoing 2-SUCCEED 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 2-SUCCEED study has fully enrolled all subjects in two cohorts.
The primary endpoint in the IgAN cohort was met and based on this SC0062 has been granted Breakthrough Designation from NMPA, whereas the study results in the DKD cohort expected in the fourth quarter of 2024. 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 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 Or LinkedIn BioCity Biopharma Contact: [email protected] [email protected] SOURCE BioCity Biopharma MENAFN04112024003732001241ID1108850865 Legal Disclaimer: MENAFN provides the information “as is” without warranty of any kind.
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