Aligos Therapeutics Doses First Subject in Phase 1 Proof-of-Concept Study of Small Molecule Drug Candidate ALG-000184 for Chronic Hepatitis B
SOUTH SAN FRANCISCO, Calif., Oct. 30, 2020 (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 it has dosed its first subject in a first-in-human Phase 1a/b clinical trial, ALG-000184-201 (NCT04536337). The study will evaluate ALG-000184, a small molecule class II capsid assembly modulator (CAM) that targets hepatitis B virus (HBV) capsid assembly as well as the establishment of covalently closed circular DNA (cccDNA).
“We are excited to advance ALG-000184 into clinical studies,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “In collaboration with Dr. Raymond Schinazi’s laboratory at Emory University, our experienced discovery and development team has optimized ALG-000184 to have best-in-class pharmacological potential. We look forward to learning how these optimized drug properties may translate into benefits for patients living with chronic hepatitis B.”
Matthew W. McClure, M.D., Chief Medical Officer at Aligos, noted, “ALG-000184-201 is a multipart Phase 1a/1b umbrella trial that will evaluate the safety and pharmacokinetics of single and multiple ascending doses of ALG-000184 in healthy volunteers, and the antiviral activity of ALG-000184 given once-daily over 28 days in patients with chronic hepatitis B (CHB). This is Aligos’ second CHB drug candidate to enter the clinic this year and we expect the 201 study will provide important proof of concept data related to the antiviral activity of ALG-000184. We look forward to sharing initial topline results from this study in the second half of 2021.”
ALG-000184 is one of several drug candidates in Aligos’ chronic hepatitis B (CHB) portfolio, which targets different clinically validated mechanisms of action in the HBV life cycle. The portfolio also includes: ALG-010133, a S-antigen Transport-inhibiting Oligonucleotide Polymers (STOPSTM) molecule, which entered clinical development earlier this year; ALG-020572, an antisense oligonucleotide (ASO); and ALG125097, a small interfering RNA (siRNA). Initially, Aligos plans to evaluate the antiviral activity of each of these drug candidates individually in Phase 1 umbrella trials before evaluating them in combination in subsequent trials.
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 workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.
Forward Looking Statements
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 Aligos’s expectations that the 201 study will provide important proof of concept data related to the antiviral activity of ALG-000184, the timing of initial topline results from the 201 study, and Aligos’s clinical development plans for the drug candidates in its portfolio. 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 prospectus filed with the Securities and Exchange Commission on October 19, 2020, 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.
Amy Jobe, Ph.D.
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