SanegeneBio Announces First-in-Human Phase 1 Clinical Data of SGB-9768, a Novel siRNA Therapeutic Targeting Complement C3 for Complement-Mediated Kidney Diseases

Dec 12, 2024 07:20 CST Updated 07:20

SANEGENEBIO

Small Nucleic Acid Drug Developer

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December 12, 2024

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On December 10, SANEGENEBIO (Suzhou) Co., Ltd. ("SANEGENEBIO") announcedFirst Disclosed at the 8th Complement Drug Development ConferenceSGB-9768, a small interfering RNA (siRNA) candidate drug targeting complement factor C3Part of the Phase I clinical trial data, the drug is intended forTreatment of Complement-Mediated Kidney DiseasesAccording to the press release, SGB-9768 performedOutGood safety and tolerability,A dose-dependent, significant and sustained decrease in C3 levels and complement pathway activity was observed simultaneously.。

Complement SystemIt is an important component of innate immunity, playing a regulatory role in adaptive immune responses and performing crucial immune and physiological functions in the human body. It protects the body from infections and clears dead cells and apoptotic substances. However, once the complement system is abnormally regulated or excessively activated, it can induce inflammation and damage self-tissues, causing immune injury. This is closely related to the occurrence and development of some blood diseases, ophthalmic diseases, and kidney diseases.

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Chronic Kidney DiseaseIt is a major public health issue in China and even globally, with a prevalence rate of 10.8% in China, meaning that one out of every 10 adults suffers from chronic kidney disease. The majority of kidney diseases involve complement-mediated pathogenesis, and the main complement-mediated kidney diseases include IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis.

Currently, the treatment progress for complement-mediated kidney diseases is limited, and many complement-targeting drugs are still in clinical research stages, indicating a significant unmet clinical need in this field. Complement inhibition is expected to become a new therapeutic target for treating complement-mediated kidney diseases. Complement C3 is a crucial component of the complement system that connects upstream activation pathways with terminal pathways. Inhibition of C3 activity has been shown to have a significant complement-inhibiting effect and can serve as a powerful therapeutic target for such diseases. Therefore,Developing safe and effective siRNA drugs targeting complement C3 holds significant clinical application value for complement-mediated kidney diseases.。

SGB-9768 is a siRNA drug independently developed by SANEGENEBIO that targets the complement C3 protein. It is delivered to liver cells using SANEGENEBIO's uniquely innovative next-generation LEAD™ GalNAc technology.Inhibition of C3 synthesis via the RNAi mechanism, thereby suppressing complement activation, for the treatment of complement-mediated kidney diseases, including IgA nephropathy, C3 glomerulopathy, immune complex-mediated membranoproliferative glomerulonephritis, dry age-related macular degeneration, paroxysmal nocturnal hemoglobinuria, and other renal and hematological diseases. Preclinical trial data show that SGB-9768 can achieve a dosing frequency of once every 3 or 6 months and can effectively and continuously reduce C3 synthesis. SANEGENEBIO believes that SGB-9768 is expected to become “First in China, World Leading"Targeted complement factor C3 siRNA drug.

It is reported that this project announced by SANEGENEBIO was conducted in New Zealand and China.Randomized, Double-blind, Placebo-controlled, Single Ascending DoseThe Phase I study primarily aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SGB-9768 in healthy subjects. As of December 1, 2024, a total of 55 subjects have been randomly assigned to receive either SGB-9768 or placebo treatment. Trial data indicate that after a single subcutaneous injection, SGB-9768 demonstrated good safety and tolerability, along with a dose-dependent, significant, and sustained reduction in C3 levels and complement pathway activity. Compared with other siRNAs targeting the same pathway, SGB-9768 exhibited higher knockdown efficiency of the target protein C3 at a lower dose.

About SANEGENEBIO

SANEGENEBIO, founded in 2021, is dedicated to developing novel small nucleic acid drugs based on RNA interference (RNAi) technology and has research and development centers in both China and the United States. The founding team consists of seasoned experts in the field of nucleic acid drugs, with years of experience in nucleic acid drug development and cutting-edge technical expertise. SANEGENEBIO has established a globally leading nucleic acid drug platform with proprietary intellectual property, featuring chemical modification and both hepatic and extrahepatic delivery technologies, enabling more efficient knockdown of disease-causing genes. The company has rapidly advanced the research and development of a series of small nucleic acid products covering cardiovascular and metabolic diseases, immune-related diseases, and neurological disorders. SANEGENEBIO is committed to scientific innovation, creating novel RNAi therapeutics to address unmet global medical needs and benefit patients and their families.

References:

1.https://mp.weixin.qq.com/s/Ks2-Ut6JJyppclh8lwzWOw

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