Aligos Therapeutics Begins Dosing with NASH Drug Candidate, ALG-055009, in Healthy Volunteers in a Phase 1 First-in-Human Study
Aligos Therapeutics (Nasdaq: ALGS) has commenced dosing in healthy volunteers for its Phase 1 trial, Study ALG-055009-301, evaluating its THR-b agonist candidate, ALG-055009, aimed at treating nonalcoholic steatohepatitis (NASH). This cohort study seeks to assess the drug's safety, tolerability, and pharmacodynamics. Dosing in subjects with mild hyperlipidemia is expected to begin in Q1 2022, with topline data anticipated by Q3 2022. NASH currently lacks approved treatments, and Aligos aims to address this significant medical need.
- Commenced dosing in the Phase 1 trial for ALG-055009, targeting NASH.
- No approved treatments available for NASH, indicating a significant market opportunity.
- Enhanced pharmacologic properties compared to other THR-b candidates, suggesting potential for better outcomes.
- The trial is at an early stage, with results not expected until late Q3 2022.
- Inherent risks in the drug development process could delay or derail progress.
SOUTH SAN FRANCISCO, Calif., Dec. 09, 2021 (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, today announced that the company has started dosing in the first cohort of healthy volunteers in Study ALG-055009-301 (NCT05090111). The trial is evaluating Aligos’ thyroid hormone receptor beta (THR-b) agonist drug candidate, ALG-055009, for the treatment of nonalcoholic steatohepatitis (NASH).
“There are no approved treatments for the millions of people in the United States and around the world who suffer from NASH and its serious complications,” said Lawrence Blatt, Ph.D., MBA, Chairman and Chief Executive Officer of Aligos. “We believe the enhanced pharmacologic properties of ALG-055009 compared to other THR-b drug candidates in development, which have demonstrated promising pharmacodynamic and histologic improvements, bodes well for ALG-055009. We look forward to seeing the results from this important Phase 1 proof of concept study.”
Study ALG-055009-301 is a double-blind, randomized, placebo-controlled trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of ALG-055009 in healthy volunteers and in subjects with hyperlipidemia, respectively. Dosing in subjects with mild hyperlipidemia is projected to begin in Q1 2022 with topline data in this population expected by
Q3 2022.
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 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 regarding our belief the enhanced pharmacologic properties of ALG-055009 compared to other THR-b drug candidates in development boding well for ALG-055009. 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. 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 4, 2021, and its future periodic reports to be filed 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.
Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com
FAQ
What is Study ALG-055009-301 about?
When will topline results for ALG-055009 be available?
Why is ALG-055009 significant for NASH treatment?
What are the next steps for Aligos after this trial?
