SHANGHAI,Nov. 5,2024 -- 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 highrisk 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:

SC0062 Met the Primary Endpoint of Reducing Urinary Protein Excretion in the IgAN Cohort: At week 12,subjects receiving SC0062 at doses of 5 mg,and 20 mg showed geometric mean reductions from baseline in 24-hour urine protein-to-creatinine ratio (UPCR) of 39.2%,33.7%,and 48.3%,respectively,compared to 16.5% in the placebo group.

SC0052 Met Secondary Endpoint 1:At week 12,the proportion of subjects achieving greater than a 30% reduction in UPCR was 48.5%,62.5%,and 71.0% in those treated with SC0062 at doses of 5 mg,and 20 mg,compared to 33.3% in the placebo group. Respective reductions of UPCR by 40% were achieved in 45.5%,37.5%,and 64.5% of subjects in SC0062 dose groups,compared to 18.2% in the placebo group. The respective proportions of subjects achieving a 50% reduction in UPCR were achieved by 33.3%,21.9%,and 51.6% per SC0062 dose group versus 12.1% in the placebo group.

SC0062 Met Secondary Endpoint 2:At week 24,and 20 mg had geometric mean reductions from baseline in 24-hour UPCR of 39.5%,46.1%,and 62.3%,compared to 22.1% in the placebo group.

Subgroup Analysis:The proportion of subjects receiving SGLT2 inhibitors as background therapies in the four groups ranged from 46% to 47%. SC0062 at the various doses evaluated consistently reduced UPCR regardless of the use of SGLT2 inhibitors as background therapy or the magnitude of UPCR prior to treatment.

Renal Function:In the early stage of treatment,no acute decline in the estimated glomerular filtration rate (eGFR) was observed in subjects receiving SC0062,and the eGFR values did not change significantly over 24-weeks of SC0062 treatment.

Safety: SC0062 was well-tolerated,with no increase in the rate of peripheral edema or the risk of fluid retention,a common side effect of other IgAN treatments,compared to placebo. The rates of edema for placebo and SC0062 at 5 mg,and 20 mg were 15%,6%,3%,and 3%,respectively. Additionally,SC0062 treatment did not result in weight gain or an increase in NT-pro-BNP levels.

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,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 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 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.

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