- NIAID contract will support conducting nonclinical and clinical studies to advance ALG-097558 into future Phase 2/3 studies

- This is the second NIH-funding received to advance the development of ALG-097558   

- First in human Phase 1 study evaluating single/multiple doses of ALG-097558 in healthy volunteers is ongoing

- Aligos plans to continue to seek external funding to advance ALG-097558 beyond the ongoing Phase 1 first in human study

SOUTH SAN FRANCISCO, Calif., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that it has been awarded an $8.5 million National Institute of Allergy and Infectious Diseases (NIAID) contract to conduct nonclinical and clinical studies to advance its pan-coronavirus protease inhibitor ALG-097558 into future Phase 2/3 studies.

“It is an honor to be awarded this NIAID contract, which is our second NIH-funding received for the development of novel inhibitors of the coronavirus 3CL protease,” said Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics. “Given that ALG-097558 potently inhibits all forms of coronavirus tested to date (SARS-CoV, MERS-CoV, SARS-CoV-2 and seasonal coronavirus), we believe that this compound will be important for the ongoing COVID-19 endemic as well as for the treatment of emergent novel coronavirus infections in humans in the future. These non-dilutive external funds will enable Aligos to continue to advance the ALG-097558 program beyond the ongoing Phase 1 study, which is evaluating single and multiple doses in healthy volunteers.”

About ALG-097558

ALG-097558 is a potent, pan-coronavirus small molecule inhibitor of the viral 3CL protease, which is currently being evaluated in an ongoing first-in-human study in healthy volunteers (NCT05840952). The program is part of a collaboration and license agreement with KU Leuven, including its Centre for Drug Design and Discovery (CD3), a drug discovery unit and investment fund of KU Leuven, and the Rega Institute for Medical Research. ALG-097558 has been pharmacologically optimized, resulting in a favorable drug-drug interaction profile and a higher barrier to resistance compared to other PIs in development. The preclinical activities of the ALG-097558 program were partially funded through a grant from the National Institutes of Health (NIH) and the NIAID’s Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern program through the Metropolitan AntiViral Drug Accelerator (MAVDA) consortium. The ALG-097558 program is now also being funded with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93023C00052, which will partially support the further clinical development of ALG-097558.  

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 liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best in class therapeutics for nonalcoholic steatohepatitis (NASH) and viruses with high unmet medical need such as coronaviruses and chronic hepatitis B (CHB).

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, Aligos’ belief that this compound will be important for the ongoing COVID-19 endemic as well as for the treatment of future potential emergence of novel coronavirus species from animals to humans; that these non-dilutive external funds will enable Aligos to continue to advance the ALG-097558 program beyond the ongoing Phase 1 study; and Aligos’ plans to continue to seek external funding to advance ALG-097558 beyond the ongoing Phase 1 first in human study. 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’ 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’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, and changes in the competitive landscape. 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’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 3, 2023 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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