SHANGHAI,Oct. 14,2024 --BioCity Biopharma announced that a late-breaking clinical trial abstract of its endothelin receptor type A (ETA) selective antagonist SC0062 has been selected for oral presentation at ASN Kidney Week 2024 which will take place from October 23 to 27 in San Diego,USA. The outstanding clinical data will be published simultaneously in JASN,the leading kidney journal in the world.
The abstract titled "SC0062,a New SelectiveEndothelin Receptor Type A Antagonist in lgA Nephropathy" will be presented by Dr. Hiddo Lambers Heerspink from the University Medical Center Groningen.
The details of presentation as below:
Oral Abstract Session
Session Title：Late-Breaking Science Orals -2
Session Date/Time：October 26,2024 from 4:30PM to 6:00 PM
Session Room: Room 6C (Convention Center)
Abstract Publication #：SA-OR103
Presentation Time: 5:30 PM to 5:40 PM
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 (IgAN) with proteinuria. The randomized double-blind,placebo-controlled Phase 2 trial of SC0062 (2-SUCCEED) demonstrated a clinically meaningful and statistically significant reduction inproteinuria in IgAN with a clear dose-response relationship and good safety profile.The 2-SUCCEED study is ongoing for the diabetic kidney disease (DKD) cohort with results are expected in the near future.
Currently,BioCity is planning Phase 3 clinical trials of SC0062 in China and worldwide intended for regulatory approval of SC0062 for IgAN as well as for the chronic kidney disease (CKD).
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 2-SUCCEED study has fully enrolled all subjects in two cohorts. The primary endpoint in the IgAN cohort was met and based on this result SC0062 has granted BTD from NMPA and will be published in JASN,whereas the study is ongoing in the DKD cohort,and the results are expected in Q4 of this year.
About BioCity
Founded inDecember 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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