Aligos Therapeutics Presents Clinical Data for its Capsid Assembly Modulator, ALG-000184, at AASLD’s The Liver Meeting® 2022

Reductions in hepatitis B surface antigen levels observed in a subset of subjects with chronic hepatitis B enrolled in Phase 1 study ALG-000184-201

SOUTH SAN FRANCISCO, Calif., Nov. 04, 2022 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, will deliver a poster presentation at The Liver Meeting® (November 4-8, 2022), hosted by the American Association for the Study of Liver Diseases (AASLD). The poster highlights clinical data for its small molecule capsid assembly modulator-empty capsid (CAM-E) drug candidate, ALG-000184, which is in development for the treatment of chronic hepatitis B (CHB). The poster includes the following key results from the ongoing Phase 1 study ALG-000184-201 (NCT04536337) in HBeAg-positive CHB cohorts that received 28 daily oral doses of ALG-000184 at either the 100 mg or 300 mg dose levels:

• ALG-000184 reduced hepatitis B surface antigen (HBsAg) levels in a subset of HBeAg-positive subjects
  • Among 7 subjects with evaluable HBsAg data who were treated with 300 mg ALG-000184, 3 subjects experienced reductions in HBsAg levels of 0.2-0.8 log₁₀ IU/mL
  • One subject in the 100 mg ALG-000184 cohort experienced a reduction in HBsAg levels of 0.5 log₁₀ IU/mL
• Rapid and profound reductions in hepatitis B virus (HBV) DNA and RNA were observed in all subjects
  • HBV DNA mean decline: 4.2 (100 mg), 4.0 log₁₀ IU/mL (300 mg)
  • HBV RNA mean decline: 3.1 (100 mg), 2.6 log₁₀ copies/mL (300 mg)

“We are excited about these preliminary data on the most advanced candidate in Aligos’ CHB portfolio,” said Lawrence Blatt, Ph.D., MBA, CEO and Chairman of the Board at Aligos. “While this dataset is small and needs to be confirmed, the observed reductions in viral surface antigen over such a short duration with an oral treatment have not been seen before. Combined with the potent reductions in HBV DNA and RNA, these new data indicate that ALG-000184 may have best-in-class antiviral properties. Based on these data, we have initiated additional cohorts in this study to confirm these observations and explore the impact of treatment for up to 48 weeks on HBsAg levels.”

“The HBsAg-lowering effects of ALG-000184 over this short dosing period are unprecedented for CAMs and therefore very exciting,” said Ed Gane, Professor of Medicine at the University of Auckland and an Investigator in the study. “If this decline in HBsAg levels continues during longer durations of therapy, then oral CAM-E drugs could become an important component of a combination regimen that can achieve functional cure.“

Aligos’ poster presentations at The Liver Meeting collectively highlight new data from the company’s drug candidates targeting chronic hepatitis B (CHB) and nonalcoholic steatohepatitis (NASH) and are available on the Aligos website at Scientific Presentations & Conferences.

Poster details

Title: Safety, pharmacokinetics (PK), and antiviral activity of the capsid assembly modulator (CAM) ALG-000184 in subjects with HBeAg positive chronic hepatitis B (CHB)
Poster Number: 1329
Abstract Number: 33693
Presenter: Jinlin Hou, M.D., Nanfang Hospital of Southern Medical University

About Aligos

Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the discovery and development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including, without limitation, statements that the new data indicate that ALG-000184 may have best-in-class antiviral properties and if the decline in HBsAg levels continues during longer durations of therapy, that oral CAM-E drugs could become an important component of a combination regimen that can achieve functional cure. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including Aligos’s clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic and the ongoing conflict between Russia and Ukraine. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 2, 2022 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.

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