Coronavirus protease inhibitor, ALG-097558, has demonstrated antiviral activity in vivo and promising pan-coronavirus activity in vitro
First-in-human studies anticipated to begin in H1 2023
SOUTH SAN FRANCISCO, Calif., Dec. 08, 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 the company presented the progress to date on the development of an oral pan-coronavirus therapeutic at the 2022 Respi DART meeting that was held December 6 – 8, 2022, in Los Cabos, Mexico.
Andreas Jekle, Ph.D., Senior Director of Biology at Aligos, delivered Aligos’ presentation, titled “Preclinical Evaluation of ALG-097558: A Novel, Orally Bioavailable Pan-Coronavirus 3CLpro Inhibitor for the Treatment of COVID-19.” During his presentation, Dr. Jekle indicated that in biochemical and cellular assays, ALG-097558 demonstrated potent, pan-coronavirus antiviral activity. In human airway epithelium cell cultures, ALG-097558 demonstrated efficient inhibition of viral replication with EC99.9 values of 5.3 and 54 nM, respectively, with or without 40% human serum. In the SARS-CoV-2 hamster infection model, efficient reduction of viral replication was demonstrated using a therapeutic dosing regimen with low oral doses of ALG-097558. Additionally, ALG-097558 retained a favorable antiviral activity profile against known 3CLpro resistance mutations. Finally, the ALG-097558 ADME profile predicts a 370-600 mg twice-daily dosing regimen in humans without the need for ritonavir boosting.
“As supported by the data in Dr. Jekle’s presentation, our 3CLpro inhibitor, ALG-097558, demonstrates superior potency against SARS-CoV-2, does not require ritonavir boosting and has the potential to have a higher barrier to resistance than other 3CLpro inhibitors such as nirmatrelvir,” said Lawrence Blatt, Ph.D., MBA, CEO and Chairman of the Board at Aligos. “IND-enabling nonclinical studies are in progress, and we look forward to beginning first-in-human clinical trials during the first half of 2023.”
Aligos’ candidate, ALG-097558, is being developed through a collaboration between Aligos and the Centre for Drug Design and Discovery (CD3), Cistim and the Rega Institute at the KU Leuven, Leuven, Belgium.
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 ALG-097558 potentially having a higher barrier to resistance than other 3CLpro inhibitors such as nirmatrelvir and Aligos’ plan to begin first-in-human clinical trials during the first half of 2023. 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, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic and the ongoing 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’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 2, 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.
Amy Jobe, Ph.D.
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Corey Davis, Ph.D.
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