Single ascending doses to be evaluated in healthy volunteers in Q4 2022
Single ascending doses to be evaluated in subjects with chronic hepatitis B beginning in Q1 2023
SOUTH SAN FRANCISCO, Calif., Oct. 14, 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, reported today that dosing with ALG-125755, an siRNA targeting the production of hepatitis B surface antigen (HBsAg), was initiated in healthy volunteers in Study ALG-125755-501 (NCT05561530).
“Emerging data continue to indicate that siRNA drugs targeting HBsAg production have the potential to become a cornerstone therapy to achieve functional cure in chronic hepatitis B,” said Lawrence Blatt, Ph.D., MBA, CEO and Chairman of the Board at Aligos. “Drugs in this class have generally been well tolerated and have consistently lowered HBsAg levels with more convenient dosing frequencies compared to other injectable HBsAg lowering agents. This, coupled with the longer duration of action observed in nonclinical studies for ALG-125755 compared to other siRNAs, suggests that ALG-125755 has the potential to be administered less frequently than other drugs in this class.”
“This is an important first step in the clinical evaluation of the safety, pharmacokinetics, and antiviral activity of ALG-125755,” said Matthew W. McClure, M.D., Chief Medical Officer of Aligos. “We plan to evaluate single ascending doses across multiple cohorts of healthy volunteers in Q4 2022. Following that, beginning in Q1 2023, we then plan to evaluate single ascending doses across multiple cohorts of subjects with chronic hepatitis B. If the safety, pharmacokinetics, and pharmacodynamics of ALG-125755 in Phase 1 are favorable, we then plan to combine this drug with other mechanisms of action in Phase 2, where we hope to achieve high rates of functional cure.”
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.
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 regarding, siRNA drugs targeting HBsAg production having the potential to become a cornerstone therapy in the effort to achieve functional cure in chronic hepatitis B; ALG-125755 having the potential to be administered less frequently than other drugs in this class; and our plans (i) to evaluate single ascending doses across multiple cohorts of healthy volunteers in Q4 2022, (ii) to evaluate single ascending doses across multiple cohorts of subjects with chronic hepatitis B beginning in Q1 2023 and (iii) to combine this drug with other mechanisms of action in Phase 2 if the safety, pharmacokinetics, and pharmacodynamics of ALG-125755 in Phase 1 are favorable. 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 August 4, 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.
Amy Jobe, Ph.D.
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