BioCity's SC0062 Meets Primary Endpoint in IgA Nephropathy 2-SUCCEED Trial

BioCity Biopharma has announced that its novel drug, SC0062, has achieved the primary goal of reducing proteinuria in patients with chronic kidney disease (CKD) in the 2-SUCCEED trial. The trial is a phase 2 study involving diabetic kidney disease (DKD) patients, and it demonstrated significant and meaningful reductions in proteinuria with a clear dose-response relationship and a good safety profile. Notably, there were no cases of fluid retention in patients treated with SC0062, and those on SGLT2 inhibitors also showed a favorable safety profile when combined with SC0062. The data will be presented at upcoming scientific conferences.

SC0062 is a highly selective endothelin receptor A (ETA) antagonist intended to improve renal blood flow, reduce proteinuria, and mitigate inflammatory and fibrotic processes associated with CKD. It was specifically designed to avoid the common adverse effect of fluid retention seen with less selective endothelin antagonists due to endothelin receptor B (ETB) blockade.

Dr. Hiddo Lambers Heerspink, a distinguished expert in CKD clinical trials, expressed his excitement over the trial results, particularly the strong dose-response relationship and lack of fluid retention. He anticipates collaborating further with BioCity to advance SC0062 for CKD patients.

Dr. Ivy Wang, Co-founder and CSO of BioCity, highlighted how increased selectivity for ETA receptors can reduce adverse effects and improve therapeutic efficacy. She emphasized the novel molecule's performance in the 2-SUCCEED study as validation of SC0062's design and development. Wang reiterated BioCity's commitment to providing safe, effective, and reliable treatments for CKD patients worldwide.

BioCity's CEO, Dr. Yong Jiang Hei, shared his enthusiasm about the positive trial results, pointing out the significant unmet medical need for CKD treatments. The successful completion of patient enrollment in the DKD cohort supports their optimism for future outcomes. These results mark a milestone for BioCity, setting the stage for a global phase 3 trial and eventual worldwide regulatory approval.

SC0062's high selectivity for ETA over ETB is anticipated to offer greater potential in reducing CKD progression while minimizing safety risks associated with less selective drugs. Preclinical studies and Phase 1 trials have already demonstrated SC0062's favorable safety profile and tolerability, with no fluid retention observed.

The ongoing phase 2 study evaluates SC0062's efficacy and safety in CKD patients with proteinuria. This multi-center, randomized, double-blind, placebo-controlled study includes two cohorts: IgAN and DKD. Led by Professor Jianghua Chen, the study is conducted at over 40 sites nationwide. The IgAN cohort has met its primary endpoint, and results from the DKD cohort are expected later this year.

Founded in December 2017, BioCity Biopharma is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for cancer, autoimmune disorders, and CKD. BioCity's pipeline includes over 10 drug candidates in various stages of development, including small molecules, monoclonal antibodies, and antibody-drug conjugates (ADC).

Currently, SC0062 is in phase 2 clinical development for CKD, with planning underway for a global phase 3 registration trial. BioCity's oncology assets also include first-in-class ADCs targeting CDH3 and GPC3, WEE1 and ATR inhibitors for DNA damage response pathways, and a TIM-3 targeting monoclonal antibody in collaboration with AstraZeneca.