SOUTH SAN FRANCISCO, Calif., March 08, 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 delivered a presentation on its SARS-CoV-2 3CLpro inhibitor candidate, ALG-097111, at the 28th Conference on Retroviruses and Opportunistic Infections, being held virtually March 6 to March 10, 2021, during the meeting’s Science Spotlight sessions on Saturday, March 6. Aligos performed all research in collaboration with Belgian University KU Leuven, in particular its Centre for Drug Design and Discovery (CD3), and the Rega Institute for Medical Research.
“Along with our collaborators at CD3 and the Rega Institute, we are proud to have shown what we believe is the first instance of in vivo evidence of SARS-CoV-2 inhibition with a therapeutic candidate in the class of SARS-CoV-2 3CLpro inhibitor compounds,” said Pierre J.M.B. Raboisson, Pharm.D. Ph.D., Executive Vice President, Head of Small Molecule Medicinal Chemistry and European Site Head at Aligos. “We have also observed highly specific, selective activity in vitro that is consistent with the robust viral inhibition we see in aggressive animal models of infection. These findings represent a significant advance toward a highly targeted therapeutic candidate that is urgently needed as the COVID-19 pandemic persists.”
The presentation, titled “The 3CLpro Inhibitor ALG-097111 Potently Inhibits SARS-CoV-2 Replication in Hamsters,” demonstrated that Aligos’ nonclinical SARS-CoV-2 therapeutic candidate, ALG-097111, potently inhibited SARS-CoV-2 replication in vivo in the lungs of SARS-CoV-2-infected hamsters, one of the most severe animal models of SARS-CoV-2 infection available. When ALG-097111 was dosed in hamsters challenged with SARS-CoV-2, the authors observed a robust and significant 3.5 log10 (RNA copies/mg) reduction of the viral RNA copies and 3.7 log10 (TCID50/mg) reduction in the infectious virus titers in the lungs. These results provide the first in vivo validation for the SARS-CoV-2 3-chymotrypsin-like cysteine protease (3CLpro), an essential SARS-CoV-2-encoded enzyme, as a promising therapeutic target in COVID-19.
The anti-SARS-CoV-2 activity of ALG-097111 was confirmed in human small airway epithelial cell cultures: when ALG-097111 was added at a concentration of 1µM to the basolateral side of the cultures, the compound significantly reduced viral RNA yield at the apical site of the culture by over 3 log10 RNA copies/mg.
ALG-097111 also demonstrated high specificity (IC50 = 7 nM) and selectivity in vitro for the viral protease relative to the similar human protease cathepsin L (IC50 > 10 µM), whose inhibition presents potential safety and efficacy concerns for other 3CLpro inhibitors in development.
Aligos CEO Lawrence Blatt, Ph.D., MBA, added, “As the COVID-19 pandemic evolves, new strains of SARS-CoV-2 have emerged that may be resistant to vaccine-mediated immune responses. We therefore see a significant need to develop treatment options that effectively block SARS-CoV-2 replication in patients who either have not been vaccinated or who are infected with vaccine-resistant strains. The demonstration of potent preclinical activity in Aligos’ viral protease inhibitor candidate is an important advancement toward this goal.”
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.
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 the advancement of any Aligos SARS-CoV-2 3CLpro inhibitor compound (e.g., ALG-097111) as a targeted therapeutic candidate and the development of treatment options that effectively block SARS-CoV-2 replication in patients who either have not been vaccinated or who are infected with vaccine resistant strains. 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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Corey Davis, Ph.D.
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