Aligos Therapeutics, Inc. (Nasdaq: ALGS) has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ALG-000184, an oral capsid assembly modulator (CAM-E) being developed for the treatment of chronic hepatitis B (CHB). The company plans to initiate a Phase 1 Drug-Drug Interaction (DDI) study to evaluate the pharmacokinetic effects of cytochrome P450 inhibitors and inducers on ALG-000184.
Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics, stated, "The acceptance of our third U.S. IND is an important milestone for Aligos. This IND clearance allows us to begin the next stages of our clinical development for ALG-000184, including the advancement of the compound into Phase 2 clinical trials."
Phase 2 Trial Design
The planned Phase 2 clinical trial, with a filing expected in Q1 2025, will be a randomized, double-blind, active-controlled study. It will compare ALG-000184 to the standard of care in both HBeAg-positive and HBeAg-negative CHB subjects.
ALG-000184: Mechanism and Potential
ALG-000184 is designed to inhibit multiple components of the HBV lifecycle, potentially leading to more complete viral suppression compared to other therapeutic modalities. Hardean Achneck, MD, Chief Medical Officer at Aligos Therapeutics, noted, "ALG-000184 has demonstrated impressive data to date with broad antiviral activity... We look forward to finalizing the Phase 2 study design in conjunction with KOLs and the FDA and anticipate enrolling patients next year."
Data from studies involving oral daily doses of 300 mg of ALG-000184 for up to 72 weeks have shown significant reductions in viral markers, including HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Dosing is ongoing through 96 weeks, and interim data readouts are expected at upcoming scientific conferences. ALG-000184 has a regulatory path endorsed by both the FDA and the CDE (China) for chronic suppressive therapy, with the potential for a superiority label compared to the current standard of care.
Background on Chronic Hepatitis B
As of July 2020, there were over 290 million chronic carriers of CHB worldwide, with approximately 30 million new infections occurring annually. Complications from CHB include cirrhosis, end-stage liver disease, and hepatocellular carcinoma, leading to approximately 900,000 deaths in 2015, according to the World Health Organization. CHB remains a primary cause of liver cancer globally, with mortality associated with HBV-related liver cancer continuing to rise.
