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

Jan 16, 2024 09:16 CST Updated 09:16

SANEGENEBIO

Small Nucleic Acid Drug Developer

｜Edited by the Peptide Biotech Content Team

2024On January 15, the official website of the Drug Clinical Trial Registration and Information Disclosure Platform showed,SANEGENEBIOInitiated an evaluation of SGB-3403 injection in healthy subjects andLow-Density Lipoprotein CholesterolSafety, Tolerability, Pharmacokinetic Characteristics, and Pharmacodynamic Characteristics in Subjects with Elevated LDL-CPhase I Clinical Trial。

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 a liver cell-targetedPCSK9The siRNA-GalNAc conjugate, delivered to liver cells using SANEGENEBIO's uniquely innovative next-generation GalNAc conjugation technology, inhibits the synthesis of liver PCSK9 protein through RNAi. SGB-3403 can be used clinically 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 the hyperlipidemia cynomolgus monkey model), achieving results with a lower dosage andFrequency of Administration, providing a sustained reduction in LDL-C, with the potential to lower LDL-C by 40%-70%, and is expected to become the best-in-class.

About SANEGENEBIO

SANEGENEBIO, founded in early 2021, is a biopharmaceutical company dedicated to developing novel small nucleic acid drugs based on RNA interference (RNAi) technology. The founding team has深耕多年 in the small nucleic acid field. Dr. Wang Weimin, the founder and CEO, is one of the leading small nucleic acid drug chemists in the industry. He developed one of the world's first lipid nanoparticle delivery platforms for nucleic acid therapy and pioneered the liver-targeted GalXC technology as well as extrahepatic delivery platforms. The core team has extensive experience in drug research and development, non-clinical and clinical studies, industrialization, and business development.

Source:

1.PharmCube

2. SANEGENEBIO - Official Website (sanegenebio.com)