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• Company to conduct a Phase 1 Drug-Drug Interaction Study

• Phase 2 filing on track for Q1 2025

SOUTH SAN FRANCISCO, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) for a Phase 1 Drug-Drug Interaction (DDI) study of ALG-000184, a capsid assembly modulator (CAM-E) for the treatment of Chronic Hepatitis B (CHB).

“The acceptance of our third U.S. IND is an important milestone for Aligos,” said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “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. ALG-000184 is the first novel, oral drug candidate for the treatment of HBV infection that can inhibit multiple components of the viral lifecycle, leading to more complete suppression of the virus compared to other therapeutic modalities.”

The DDI study is designed to evaluate the effect of a cytochrome P450 inhibitor and inducer on ALG-000184 pharmacokinetics. In addition, Phase 2 enabling activities are ongoing, with a planned filing in Q1 2025 for the Phase 2 study. This clinical trial will be a randomized, double-blind, active controlled study of ALG-000184 vs. standard of care in HBeAg-positive and HBeAg-negative CHB subjects.

“ALG-000184 has demonstrated impressive data to date with broad antiviral activity,” stated Hardean Achneck, MD, Chief Medical Officer at Aligos Therapeutics. “ALG-000184 has the potential to improve outcomes compared to the current standard of care. 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 ≤72 weeks following an oral daily dose of 300 mg ALG-000184 has demonstrated the ability to disrupt the entire HBV lifecycle through best-in-class reductions of the relevant viral markers: HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Dosing through 96 weeks is ongoing, with interim data readouts expected at upcoming scientific conferences. ALG-000184 has a clear regulatory path endorsed by the FDA and CDE (China) for chronic suppressive therapy with a potential superiority label compared to standard of care.

About ALG-000184

ALG-000184 was derived from initial IP licensed from the laboratory of Dr. Raymond Schinazi at Emory University, which was further optimized by Aligos. ALG-000184 is a potent potential best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for chronic hepatitis B (CHB). Phase 1a studies have demonstrated after single and multiple daily doses that ALG-000184 was well-tolerated, with no safety signals observed, and demonstrated linear PK and excellent antiviral activity. In longer term Phase 1b studies of ALG-000184 300mg QD x ≤96 weeks ± Entecavir (ETV) and ALG-000184 monotherapy have demonstrated best-in-class sustained reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Dosing is ongoing through 2025 with interim data readouts expected at upcoming scientific conferences. Phase 2 enabling activities are ongoing, with a planned Phase 2 IND filing in Q1 2025. ALG-000184 has a clear regulatory path endorsed by the FDA and CDE (China) for chronic suppressive therapy with a potential superiority label compared to standard of care.