Recently, the Phase Ib/II multi-center clinical trial of LW231, the world's first dual-function, dual-target Class 1 new drug for the complete cure of hepatitis B independently developed by Longwood Biopharmaceuticals, was officially initiated.
Professor Qiu Yunqing from The First Affiliated Hospital of Zhejiang University School of Medicine serves as the Principal Investigator (PI) of this trial, and the hospital has become the first site to launch the study. Subsequently, the trial will be sequentially initiated and advanced across approximately 20 clinical sites nationwide.
This study is a Phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetic profiles, preliminary efficacy, and pharmacodynamic characteristics of LW231 in multiple-dose, dose-escalation regimens, as well as in combination with nucleos(t)ide analogues, in patients with chronic hepatitis B virus (HBV) infection.
LW231 is the world's first (First-in-Class, FIC) class 1 new drug for the complete cure of hepatitis B to enter clinical development, independently developed by Longwood Biopharmaceuticals. It can effectively inhibit viral replication while activating the response of the liver's innate immune system, stimulating liver macrophages to clear HBV-infected hepatocytes. This mechanism enables negative conversion of all virological indicators with no rebound after treatment discontinuation, achieving a global breakthrough in the complete cure of hepatitis B and establishing itself as a milestone drug in the field of hepatitis B diagnosis and treatment.
Additionally, LW231 is the world's first innovative drug applying the cGAS/STING pathway to immune anti-viral therapy. According to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition), the hallmark indicator of a complete cure for hepatitis B is defined as the clearance of HBV DNA (including nuclear covalently closed circular DNA, cccDNA) in hepatocytes. Currently, LW231 is the only drug in the world that meets this criterion.
