Subjects experienced a 2.9 log10 IU/mL mean reduction in HBV DNA levels after 14 days’ dosing with 100 mg ALG-000184
Half (4 out of 8) of these subjects had HBV DNA levels below the lower limit of quantitation (LLOQ) on Day 14
SOUTH SAN FRANCISCO, Calif., June 10, 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 a poster describing data from the ongoing Study ALG-000184-201 (NCT04536337) will be presented at the HBV-TAG 2021 Conference, taking place virtually June 11-12, 2021. The poster is expected to be made available to conference registrants through the online HBV-TAG portal at the start of the meeting on Friday, June 11, 2021. The poster will be available subsequently on the “Scientific Presentation and Publications” page in the “Presentations” section of Aligos’ website at www.aligos.com.
The poster details the initial safety, pharmacokinetics, and antiviral activity of multiple daily oral doses of ALG-000184 in healthy volunteers and CHB subjects who were treatment-naïve or currently not treated. In addition to being well tolerated, 100 mg of ALG-000184 given over 14 days resulted in a mean reduction in hepatitis B virus (HBV) DNA of 2.9 log10 IU/mL. Additionally, 4 of the 8 (50%) subjects receiving ALG-000184 had HBV DNA levels at Day 14 below the LLOQ (Roche COBAS assay, LLOQ<10 IU/mL). By comparison, there was no meaningful change in HBV DNA observed in the 2 subjects who received placebo.
"We are excited to share these promising initial data,” said Lawrence Blatt, Ph.D., MBA, CEO of Aligos. “We believe they support our general approach to drug development, which is to identify and develop drug candidates which have clinically validated mechanisms of action and have potentially best in class properties. Both our clinical stage CAM and STOPS™ programs continue to advance, with dosing in CHB patients ongoing, and we plan to share additional data for these programs at a future conference in the second half of this year. Additionally, our CHB antisense oligonucleotide (ASO) as well as our nonalcoholic steatohepatitis (NASH) thyroid hormone receptor beta agonist programs continue to be on track to start clinical trials in the same time frame.”
“These early results are very impressive,” noted Ed Gane, Professor of Medicine at University of Auckland and the study’s Principal Investigator. “HBV DNA levels declined rapidly and substantially after initiation of dosing with ALG-000184. These data suggest that ALG-000184 has best-in-class potential in the capsid assembly modulator (CAM) drug class.”
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 CHB and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for 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 current approach of identifying and developing drug candidates having clinically validated mechanisms of action and potentially best in class properties; our continued advancement of our CAM and STOPS™ programs with ongoing dosing in CHB patients; our plan to share additional data for these programs in the second half of 2021; and the start of clinical trials for our CHB ASO and our NASH thyroid hormone receptor beta agonist programs in the same time frame. 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 May 10, 2021, as well as other documents Aligos files from time to time 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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