SanegeneBio's siRNA Drug SGB-9768 Receives Approval for Phase I Clinical Trial in New Zealand
SANEGENEBIO
Small Nucleic Acid Drug Developer
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On February 26, 2024, SANEGENEBIO announced that its self-developed siRNA drug SGB-9768 for the treatment of complement-related diseases has recently been approved by New Zealand's Medicines and Medical Devices Safety Authority (Medsafe) and the Health and Disability Ethics Committees (HDEC) to conduct Phase I clinical trials in New Zealand. This is the second siRNA drug from SANEGENEBIO to enter the clinical trial stage.
SGB-9768 is a siRNA-GalNAc conjugate targeting complement C3, delivered to liver cells using SANEGENEBIO's uniquely innovative next-generation LEAD™ GalNAc technology, inhibiting the synthesis of hepatic C3 through RNAi. The safety, efficacy, and stability of GalNAc-delivered siRNA drugs have been extensively validated by substantial data. SGB-9768 can achieve a dosing frequency of once every 3 or 6 months, offering advantages such as low treatment frequency, good patient compliance, and long-lasting efficacy. Preclinical trial data show that SGB-9768 can effectively and sustainably reduce C3 synthesis, demonstrating superior efficacy compared to competing products and showing potential to become a best-in-class drug.
This clinical study is a Phase I, randomized, double-blind, placebo-controlled, single-dose escalation trial. Its primary objective is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SGB-9768 in healthy volunteers.
Said Dr. Weimin Wang, founder and CEO of SANEGENEBIO"SGB-9768 is the first candidate drug developed by SANEGENEBIO in the field of immune-related diseases to be approved for clinical trials. It utilizes the company's proprietary LEAD™ GalNAc delivery platform, and preclinical studies have demonstrated excellent activity, durability, and safety. We will accelerate the Phase I clinical trial of SGB-9768, expecting its outstanding research results to be validated and showcased soon. Meanwhile, the company will continue to explore the application potential of the C3 target, advancing its development in various complement-related diseases, providing more and better treatment options for patients with immune-related diseases."
SANEGENEBIO has established a robust proprietary small nucleic acid drug development platform named LEAD™ (Ligand and Enhancer Assisted Delivery). The innovative technology of the LEAD™ platform expands the therapeutic scope of RNAi therapies from liver tissue to tissues beyond the liver, targeting multiple extrahepatic disease treatment sites. This fully unleashes the application potential of RNAi technology, addressing unmet medical needs in various disease areas.
R&D Pipeline
Source: SANEGENEBIO