Kidney Week

Abstract: TH-PO1259

Interim Phase 2 Results of SGB-9768, a Liver-Targeted GalNAc-siRNA-Targeting Complement C3, in IgA Nephropathy, C3 Glomerulopathy, and Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

Session Information

• Late-Breaking Research Posters
  October 22, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Zhao, Minghui, Peking University First Hospital, Beijing, China

Minghui Zhao, PhD

• Zhang, Hong, Peking University First Hospital, Beijing, China

Hong Zhang, MD, PhD

• Tan, Ying, Peking University First Hospital, Beijing, China

Ying Tan, MD

• Lv, Jicheng, Peking University First Hospital, Beijing, China

Jicheng Lv, MD

• Li, Guisen, Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China

Guisen Li, MD, PhD

• Li, Xiaowei, Fuyang People's Hospital, Fuyang, Anhui, China

Xiaowei Li, PhD

• Sheng, Lili, Suzhou Sanegene Bio Inc., Shanghai, China

Lili Sheng, PhD

• Jin, Yuyan, Suzhou Sanegene Bio Inc., Shanghai, China

Yuyan Jin, PhD

• Duan, Dan, Suzhou Sanegene Bio Inc., Shanghai, China

Dan Duan

• Yao, Xuekun, Suzhou Sanegene Bio Inc., Shanghai, China

Xuekun Yao

Group or Team Name

• Study SGB-9768-003 Investigators

Background

Complement dysregulation plays a central role in the pathogenesis of IgA nephropathy (IgAN), C3 glomerulopathy (C3G), and primary immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN). SGB-9768 is a liver-targeted GalNAc-siRNA designed to suppress complement component 3 (C3) expression.

Methods

SGB-9768-003 is an ongoing Phase 2, open-label study in patients with primary IgAN, C3G, or IC-MPGN in China. Eligible patients had UPCR ≥0.5 g/g or 24-hour urinary protein ≥0.75 g/day and eGFR ≥30 mL/min/1.73 m^2. Patients received two subcutaneous administrations 12 weeks apart (IgAN: 300 or 600 mg; C3G/IC-MPGN: 600 mg). The primary endpoint is percent change from baseline in 24-hour UPCR at Week 24. Secondary endpoints include changes in proteinuria, eGFR, safety, pharmacokinetics, pharmacodynamics, and immunogenicity.

Results

Thirty-nine patients (IgAN, n=30; C3G, n=5; IC-MPGN, n=4) completed Week 24 follow-up. At baseline, mean (SD) 24-hour UPCR was 2.49 (1.45), 1.64 (0.75), and 1.76 (1.05) g/g in the C3G/IC-MPGN, IgAN 300 mg, and IgAN 600 mg cohorts, respectively, while mean (SD) eGFR was 107.3 (24.5), 85.5 (33.7), and 79.6 (29.0) mL/min/1.73 m^2. Serum C3 declined rapidly, with mean reductions >90% by Week 4. At Week 24, geometric mean reductions in 24-hour UPCR were 63.5% (95% CI, 12.3%-84.8%) in C3G/IC-MPGN cohort, 58.6% (95% CI, 40.0%-71.4%) in 300 mg IgAN cohort, and 74.1% (95% CI, 61.4%-82.6%) in 600 mg IgAN cohort. eGFR remained generally stable through Week 24. SGB-9768 was generally safe and well tolerated, with no major safety concerns.

Conclusion

Two SC administrations of SGB-9768 were associated with substantial and clinically meaningful reductions in proteinuria across IgAN, C3G, and IC-MPGN, accompanied by stable kidney function through week 24.