Aligos Therapeutics Receives FDA Clearance for ALG-000184 IND Application

Aligos Therapeutics, Inc., a biopharmaceutical company focusing on liver and viral diseases, announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1 Drug-Drug Interaction (DDI) study of ALG-000184. This compound is a capsid assembly modulator (CAM-E) designed to treat Chronic Hepatitis B (CHB). The IND clearance is a significant step for Aligos, enabling the company to proceed with further clinical development of ALG-000184, including its transition into Phase 2 clinical trials.

ALG-000184 stands out as the first innovative oral drug candidate for HBV infections that can inhibit several components of the viral lifecycle. This multi-faceted inhibition is expected to offer more complete viral suppression compared to existing treatments. The Phase 1 DDI study aims to investigate the influence of a cytochrome P450 inhibitor and inducer on the pharmacokinetics of ALG-000184. Concurrently, activities to enable Phase 2 trials are ongoing, with the Phase 2 IND filing anticipated in the first quarter of 2025.

The planned Phase 2 clinical trial will be a randomized, double-blind, active-controlled study comparing ALG-000184 to the standard of care in treating both HBeAg-positive and HBeAg-negative CHB patients. Hardean Achneck, MD, Chief Medical Officer of Aligos Therapeutics, expressed optimism about the potential of ALG-000184 to improve patient outcomes relative to current standards. The company is finalizing the Phase 2 study design in collaboration with key opinion leaders (KOLs) and the FDA, with patient enrollment expected to start next year.

Data from Phase 1 studies have shown promising results for ALG-000184. In trials with daily oral doses of 300 mg over periods up to 72 weeks, ALG-000184 demonstrated the ability to disrupt the entire HBV lifecycle, achieving significant reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg markers. Ongoing dosing through 96 weeks continues, with interim data expected to be presented at upcoming scientific conferences. ALG-000184 has received a clear regulatory path from the FDA and the Chinese Center for Drug Evaluation (CDE) for chronic suppressive therapy, potentially offering a superior treatment option compared to current standards.

ALG-000184 originates from intellectual property licensed from Dr. Raymond Schinazi's laboratory at Emory University and has been optimized by Aligos. It is a potent small molecule designed to be a best-in-class treatment for CHB. Phase 1a studies indicated that ALG-000184 is well-tolerated with no safety concerns, exhibiting linear pharmacokinetics and strong antiviral activity. Extended studies up to 96 weeks with or without Entecavir (ETV) have confirmed sustained reductions in key viral markers. Phase 2 enabling activities continue, with the Phase 2 IND filing planned for early 2025.

Chronic Hepatitis B remains a significant global health issue, with over 290 million chronic carriers worldwide as of July 2020 and about 30 million new infections annually despite available vaccines. In 2015, more than 90 million cases were reported in China, with an additional 8 million cases across the European Union, United States, and Japan. Complications from CHB, such as cirrhosis, end-stage liver disease, and hepatocellular carcinoma, led to approximately 900,000 deaths in 2015. CHB is a primary cause of liver cancer globally, and the mortality rate from HBV-related liver cancer continues to rise.

Aligos Therapeutics is committed to improving patient outcomes by developing best-in-class therapies for liver and viral diseases. The company leverages its scientific expertise and research and development capabilities to advance a pipeline of therapeutics aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) and high-need viruses such as hepatitis B and coronaviruses.