– Final cohort of Phase 1 study projected to be complete in H1 2023 –
– Phase 2-enabling GLP toxicology studies projected to be complete in H2 2023 –
– Clinical update on all pipeline programs to be presented at the 2023 J.P. Morgan Healthcare Conference on January 12 at 10:30 a.m. PT –
SOUTH SAN FRANCISCO, Calif., Jan. 05, 2023 (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 remains on track to complete all Phase 2-enabling activities in 2023 for ALG-055009, its thyroid hormone receptor beta (THR-ß) drug candidate for nonalcoholic steatohepatitis (NASH).
“Initial Phase 1 clinical data demonstrate that ALG-055009 is favorably differentiated compared to frontrunner THR-ß drug candidates such as resmetirom,” said Lawrence Blatt, Ph.D., MBA, CEO and Chairman of the Board at Aligos. “The dose-proportional pharmacokinetics (PK) and low variability observed with ALG-055009 indicate that, compared to other THR-ß drugs, more predictable and consistent ALG-055009 exposures may be achieved across diverse patient populations. This, in turn, may result in more consistent, and potentially greater, pharmacodynamic effects. The planned upcoming Phase 2 study of ALG-055009 will be important in assessing the spectrum of activity of this molecule. We look forward to elaborating on this and the rest of our pipeline during our presentation at the upcoming JP Morgan conference in San Francisco.”
Matthew W. McClure, M.D., Chief Medical Officer at Aligos Therapeutics, added, “We are enthusiastic about the therapeutic profile of ALG-055009 compared to earlier generation THR-ß drug candidates. Our team is therefore focused on advancing ALG-055009 into Phase 2 as quickly as possible. We anticipate completing the final cohort of the Phase 1 study (NCT05090111) in H1 2023 where the relative bioavailability of the Phase 2 drug formulation will be assessed. Other Phase 2-enabling activities including the 13-week GLP toxicology studies will be conducted in parallel and are anticipated to be complete by H2 2023.”
Dr. Blatt will provide a corporate update and discuss the company’s entire pipeline, including ALG-055009, the coronavirus protease inhibitor ALG-097558, and Aligos’ hepatitis B portfolio, on Thursday, January 12, 2023, at 10:30 a.m. PT during the 41st Annual JP Morgan Healthcare Conference in San Francisco. Dr. Blatt’s presentation will also be posted on the Aligos website at the time of the conference.
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, with respect to ALG-055009, the company being on track to complete Phase 2 enabling activities in 2023; the observed dose PK and low variability indicating that, compared to other THR-ß drugs, more predictable and consistent ALG-055009 exposures may be achieved across diverse patient populations which in turn may result in more consistent, and potentially greater, pharmacodynamic effects; the anticipation of completing the last cohort of the Phase 1 study (NCT05090111) in H1 2023 where relative bioavailability of the Phase 2 drug formulation will be assessed; and the plan to conduct in parallel other Phase 2 enabling activities including 13-week GLP toxicology studies and the anticipation that they will be complete by H2 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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