Release Details

ALG-097558 demonstrates nanomolar potent antiviral activity and is up to 20-fold more active than nirmatrelvir in cell-based assays against multiple SARS-CoV-2 variants

SOUTH SAN FRANCISCO, Calif., April 04, 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, today announced that it has selected ALG-097558, a broad spectrum coronavirus protease inhibitor, as its drug candidate to move forward into development. The program is part of the 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.

“Despite the progress that vaccines have brought to combating the global COVID-19 pandemic, there remains an ongoing need for an orally administered potent antiviral therapeutic that broadly inhibits diverse strains of SARS-CoV-2 as this virus will continue to generate new variants that can potentially evade vaccine mediate immune responses,” said Lawrence Blatt, Ph.D., MBA, Chairman and Chief Executive Officer of Aligos. “The rapid advancement of ALG-097558 as a protease inhibitor that has potent activity against a wide range of coronaviruses highlights our internal and our KU Leuven collaborators’ expertise in small molecule development for antiviral indications.”

ALG-097558 has shown superior potency compared to nirmatrelvir (PF-07321332) against SARS-CoV-2 and multiple resistant variants in all cell-based assays tested to date. ALG-097558 is 9 to 20-fold more active than nirmatrelvir, depending on the variant. Evaluation against the Omicron variant demonstrates a 10-fold improvement in cell-based potency for ALG-097558 compared to nirmatrelvir. ALG-097558 exerts potent broad spectrum activity against alpha and beta coronaviruses, and its highly conserved target site indicates a high probability that it will retain potent activity against potential future SARS-CoV-2 variants.

“SARS-CoV-2 will remain a global health challenge, and despite the availability of effective vaccines, we still need potent and safe antiviral drugs to treat and prevent COVID-19,” said Johan Neyts, Ph.D., professor of virology at KU Leuven. Patrick Chaltin, Ph.D., Managing Director of CD3 added: “ALG-097558 exerts remarkable potent antiviral activity against all tested SARS-CoV2 variants. This compound has a very good profile to be further developed as a powerful drug against SARS-CoV-2 and other known, or yet unknown, coronaviruses.”

Projected efficacious doses of ALG-097558 can be achieved in humans without ritonavir boosting. Aligos expects to file a Phase 1 clinical trial application in 2H 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 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.

Please visit www.aligos.com for more information.

About KU Leuven

KU Leuven is Europe’s most innovative university (Reuters) and ranks 42nd in the Times Higher Education World University Rankings. As Belgium's largest university, KU Leuven welcomes 60,000 students from over 140 countries. Its 7,000 researchers are active in a comprehensive range of disciplines. KU Leuven is a founding member of the League of European Research Universities (LERU) and has a strong European and international orientation. University Hospitals Leuven, its network of research hospitals, provides high-quality healthcare and develops new therapeutic and diagnostic insights with an emphasis on translational research.

Please visit www.kuleuven.be for more information.

About the Centre for Drug Design and Discovery – KU Leuven

The Centre for Drug Design and Discovery (CD3) is a drug discovery platform and investment fund with a focus on the discovery and development of innovative medicines mainly starting from innovative academic research. By providing the necessary drug discovery expertise and financial resources, CD3 ensures that biomedical research carried out by universities and small biotech companies is collaboratively translated into promising new medicines. Subsequently, such new potential medicines can then be further developed by pharma or biotech industry or can form the basis for the establishment of new biotechs. CD3 was set up in 2006 by KU Leuven Research & Development and the European Investment Fund (EIF) and launched a 60 million euro fund in 2016.

Please visit www.cd3.eu for more information.

About Rega Institute

The Rega Institute for Medical Research is a biomedical research institute of KU Leuven that comprises the Laboratory of Virology and Chemotherapy, which specializes particularly in antiviral research. Medications discovered at the Rega Institute are successfully being used for the treatment of, for example, HIV, hepatitis B and infections caused by herpes viruses and several other drug candidates are in development against human rhinovirus, dengue and other (viral) diseases.

Please visit www.kuleuven.be/rega for more information.

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 SARS-CoV-2 remaining a global health challenge; the ongoing need for an orally administered potent antiviral therapeutic that broadly inhibits diverse strains of SARS-CoV-2 which will continue to generate new variants that can potentially evade vaccine mediate immune responses; the high probability that ALG-097558 will retain potent activity against potential future SARS-CoV-2 variants; ALG-097558 having a very good profile to be further developed as a powerful drug against SARS-CoV-2 and other known, or yet unknown, coronaviruses; projected efficacious doses of ALG-097558 being achieved in humans without ritonavir boosting; and Aligos’ expectations in filing a Phase 1 clinical trial application in 2H 2022.  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 developing 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 10, 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.

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