SanegeneBio Initiates Phase I Clinical Trial in China for PCSK9-Targeting RNAi Therapy SGB-3403 in Hypercholesterolemia

On January 15, the official website of the Drug Clinical Trial Registration and Information Disclosure Platform showed that SANEGENEBIO initiated a Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and pharmacodynamic characteristics of SGB-3403 injection in healthy subjects and subjects with elevated low-density lipoprotein cholesterol (LDL-C).

This study is a randomized, double-blind, parallel-group Phase I clinical trial, planning to recruit 64 subjects in China, with the dosing regimen shown in the figure below. The primary endpoints are adverse events (AE) and changes in parameters such as laboratory tests.

SGB-3403 is an siRNA-GalNAc conjugate targeting PCSK9 in hepatocytes, delivered to liver cells using SANEGENEBIO's uniquely innovative next-generation GalNAc conjugation technology, and inhibits the synthesis of PCSK9 protein in the liver through RNAi. Clinically, SGB-3403 can be used for the treatment of hypercholesterolemia, mixed dyslipidemia, and atherosclerotic cardiovascular diseases to reduce the risk of cardiovascular events.

Preclinical trial data show that SGB-3403 has good safety and tolerability, and demonstrates superior efficacy compared to reference products in multiple preclinical animal disease models (including a hyperlipidemia model in cynomolgus monkeys). With a lower dosage and reduced dosing frequency, it achieves a sustained reduction in LDL-C, lowering LDL-C by 40%-70%, with the potential to become a best-in-class treatment.

Notably, in May 2023, SGB-3403 has entered Phase I clinical trials in Australia to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SGB-3403 following subcutaneous administration in healthy subjects and those with elevated LDL-C.

Copyright © 2024 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message or send a notification to the WeChat Official Account backend, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Exciting Preview

Live Streaming