SanegeneBio Announces Clinical Progress of Two siRNA Therapeutics: SGB-9768 and SGB-3908

Aug 07, 2024 09:56 CST Updated 09:56

SANEGENEBIO

Small Nucleic Acid Drug Developer

▎WuXi AppTec Content Team Report

Recently, SANEGENEBIO in Suzhou（SanegeneBio）Continuously Welcoming TwoIn DevelopmentSmall Nucleic Acid (siRNA) New DrugTheClinical Progress. On August 6, SANEGENEBIO announced that the Phase 1 clinical study in China of its siRNA drug SGB-9768 injection was successfully administered to the first subject at Huashan Hospital Affiliated with Fudan University. Just a few days prior (On August 2, SANEGENEBIO and Innovent Biologics jointly announced,siRNA DrugsThe First-in-Human Phase 1 Clinical Study of SGB-3908 Injection Completes Dosing of the First Subject.

SANEGENEBIO, founded in 2021, is dedicated to developing novel small nucleic acid drugs based on RNA interference (RNAi) technology. The company's founder and Chief Executive Officer (CEO) is Dr. Wang Weimin. In December 2023, SANEGENEBIO announced the completion of an over 80 million USD A+ round led by Tencent Investment and OrbiMed China.Financing. Currently, the company has three RNAi drugs approved for clinical trials. In addition to the recent clinical progress just achieved,Targeting Complement C3 ProteinsiRNA TherapySGB-9768AndTargeting Angiotensinogen (AGT)ofsiRNA TherapySGB-3908，Another product of the companysiRNA Therapy Targeting Hepatocyte PCSK9SGB-3403 has also entered the clinical stage.

SGB-9768：An siRNA drug targeting the complement C3 protein, delivered to liver cells using the next-generation LEAD™ GalNAc technology, inhibits C3 synthesis through the RNAi mechanism, thereby suppressing complement activation. It holds promise for treating complement-mediated kidney diseases.Preclinical studies show that SGB-9768 can achieve everyFrequency of administration once every 3 months or 6 months, and can effectively and continuously reduce C3 synthesis, with better efficacy and good safety tolerance.Complement-mediated kidney diseases mainly include IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis, etc. Currently, the treatment progress for complement-mediated kidney diseases is limited.siRNA drugs targeting complement C3 have potential clinical development prospects for the treatment of complement-mediated kidney diseases.

SGB-9768 has entered Phase 1 clinical trials in New Zealand at the beginning of 2024. Multiple groups of subjects have been dosed so far, demonstrating good safety.Tolerability. A Phase 1 randomized, double-blind, placebo-controlled, single-dose escalation study currently conducted in China aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SGB-9768 in healthy subjects.This timeThe successful dosing of the first subject in China for SGB-9768 is considered an important milestone for the project.

SGB-3908（Innovent Biologics R&D Code: IBI3016）：A Targeted Angiotensinogen (AGT)The siRNA drug, proposed byUsed to treat hypertension.Preclinical studies show that SGB-3908 significantly reduces AGT protein and related biomarkers (ANG I, ANG II) in the serum of hypertensive cynomolgus monkeys, with a marked and long-lasting blood pressure lowering effect, and no safety issues such as hypotension were observed.In December 2023, SANEGENEBIO and Innovent Biologics reached a collaboration,Advance TogetherSGB-3908 is being developed by SANEGENEBIO, which has granted Innovent Biologics the option for future development, manufacturing, and commercialization of the drug in different regions.

Currently, SGB-3908 is undergoing a Phase 1 clinical study with single ascending doses., aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and pharmacodynamic characteristics of SGB-3908 in healthy subjects and subjects with mild hypertension.Hypertension is a common chronic disease, with over 1 billion people currently affected worldwide, and the prevalence continues to rise. Hypertension not only increases the risk of cardiovascular and cerebrovascular diseases but may also lead to complications such as kidney damage and vision loss. Although effective antihypertensive drugs are available in clinical practice, poor adherence remains a major challenge, and siRNA drugs are expected to offer patients a better treatment option.

References:

[1]SANEGENEBIO's RNAi Drug Targeting Complement C3 Completes First Participant Dosing in Phase I Clinical Study in China.Retrieved Aug 6 , 2024, from https://mp.weixin.qq.com/s/1_tBxFN2blH0eKzyE634sA

[2] SANEGENEBIO and Innovent Biologics Announce First Patient Dosed in Phase I Clinical Trial of siRNA Drug Targeting AGT.Retrieved Aug 2 , 2024, from https://mp.weixin.qq.com/s/DUwl4FkHxZf9B8KTQ1kBpg

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