-SGB-9768 demonstrates a favorable safety and tolerability profile in healthy volunteers (HVs), achieving significant, dose-dependent, and sustained reduction in serum C3 and inhibition of alternative pathway (AP) activity after single-dose subcutaneous (SC) administration-
-The results support its further investigation for the treatment of complement-mediated kidney diseases such as IgA Nephropathy (IgAN) and C3 Glomerulopathy (C3G)-
Boston, Suzhou & Shanghai – November 14, 2025 –SanegeneBio, a clinical-stage biotechnology focused on developing best-in-class RNAi medicines for obesity, cardiometabolic, and autoimmune diseases, announced that the results from Phase 1 clinical studies of SGB-9768, an experimental small interfering RNA (siRNA) medicine targeting complement C3, conducted in New Zealand and China, were presented in a poster session at the American Society of Nephrology (ASN) Kidney Week 2025. Dr. Nicholas Cross from the New Zealand Clinical Research Centre, the principal investigator of the SGB-9768 New Zealand Phase 1 study, delivered the poster presentation of the study results.
Study Methods and Subject Baseline Characteristics
The presented Phase I clinical data integrated results from the SGB-9768-001 study (hereafter “Study 001”) conducted in New Zealand and the SGB-9768-002 study (hereafter “Study 002”) conducted in China. Both studies were randomized, double-blind, placebo-controlled, single-ascending dose studies, designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single SC doses of SGB-9768 in HVs.
As of September 30, 2025, the two studies had enrolled 74 HVs (29 HVs in Study 001, 45 HVs in Study 002) and completed key data collection across 7 different dose levels. Study 001 included 5 dose cohorts (25 mg, 50 mg, 100 mg, 200 mg, 400 mg); Study 002 included 6 dose cohorts (50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg).
Subject baseline characteristics were consistent with the populations of the respective study locations: Study 001 predominantly enrolled White subjects; Study 002 enrolled exclusively Chinese subjects. Baseline characteristics were generally well-balanced across all cohorts within both studies.
Single-dose administration of SGB-9768 achieves significant, dose-dependent, and sustained reduction in serum C3, with near-complete inhibition of AP activity
- In Study 001, a single dose of 400 mg achieved a maximum reduction from baseline of 86.8% in serum C3 and 100% inhibition of AP activity at approximately Week 4 and was maintained through Week 24.
- In Study 002, a single dose of 600 mg achieved a maximum reduction from baseline of 96.3% in serum C3 and 100% inhibition of AP activity at approximately Week 4 and was maintained through Week 24.
- Across doses (50–400 mg) and visits, Study 002 showed slightly greater reductions in C3 and AP activity than Study 001.
Favorable safety and tolerability
- SGB-9768 demonstrated favorable safety and tolerability in both Phase I studies.
- There were no dose-limiting toxicities (DLTs) observed, no treatment-related serious adverse events (TRSAEs), and no discontinuations due to adverse events (AEs).
- These data from the Phase I studies support the further clinical development of SGB-9768.
Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at SanegeneBio, stated: “There is still a significant need for innovative therapies that can provide effective, long-term control of disease progression in complement-mediated kidney diseases such as IgAN and C3G. SGB-9768 leverages RNAi technology to silence C3 mRNA in hepatocytes, thereby inhibiting complement activation at its source. It has shown encouraging results in two independent Phase I studies. Following a single-dose administration, it not only achieved significant and sustained reduction in serum C3 levels and effective inhibition of the alternative complement pathway activity but also demonstrated favorable safety and tolerability. Based on these solid clinical data, we will actively advance subsequent clinical development, hoping to provide patients with an effective and convenient new treatment option.”
About Complement-Mediated Kidney Diseases
The complement system is a crucial part of innate immunity, playing a key role in protecting the body from infection and clearing dead cells and apoptotic material. However, its dysregulation or overactivation can induce inflammation, damage host tissues, and is closely associated with the development and progression of various kidney diseases. Major complement-mediated kidney diseases include IgA Nephropathy (IgAN) and C3 Glomerulopathy (C3G). IgAN (IgA Nephropathy) is one of the most common primary glomerular disease in China, with an estimated 4 million patients, predominantly affecting young and middle-aged adults. IgAN is the leading cause of end-stage renal disease (ESRD) in this demographic in China. Studies show that approximately 50% of IgAN patients with persistent proteinuria progress to ESRD within 10-20 years after diagnosis, requiring dialysis or kidney transplantation. C3G (C3 Glomerulopathy) is a rare kidney disease with a global incidence of 1-2 per million people per year, primarily affecting young adults. Approximately 50% of patients progress to ESRD within 10 years, requiring dialysis or kidney transplantation; post-transplantation, the disease recurs in 50%-70% of patients, making its clinical management extremely challenging. Both IgAN and C3G are closely associated with complement activation. They share great challenges of rapid progression and limited treatment options, significantly threatening patient survival and quality of life.
About SGB-9768
SGB-9768 is a GalNAc-conjugated experimental RNAi-based medicine designed to silence C3 mRNA in hepatocytes, thereby inhibiting complement activation. It is a potential treatment for various complement-mediated kidney diseases, including IgAN, C3G, and IC-MPGN. It has demonstrated significant, sustained reduction in C3 levels following a single subcutaneous dose, the potential for infrequent dosing and long-term efficacy. With a favorable safety profile and greater durability than comparator molecules, SGB-9768 may become a best-in-class RNAi therapeutic for complement-mediated diseases.
About SanegeneBio
SanegeneBio is a global, venture-backed, fully-integrated biotechnology company focused on developing RNAi-based therapeutics. Founded in 2021 and led by a team of RNAi veterans, the company has R&D operations in Boston, Shanghai and Suzhou. Their clear vision is that RNAi technology will power blockbuster medicines in diverse therapeutic areas, improving the quality and longevity of life for patients worldwide. This vision is being realized by advancing a fast-growing pipeline, which includes experimental medicines for autoimmune nephropathies, obesity, and cardiometabolic indications. SanegeneBio has initiated clinical trials for four experimental medicines to-date, and is committed to developing potential best-in-class and first-in-class therapeutics which leverage our industry-leading and differentiated LEAD™ tissue-selective RNAi delivery technology. For more information, please visit: www.sanegenebio.com and engage on LinkedIn.