SOUTH SAN FRANCISCO, Calif., June 05, 2024 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced positive data from six poster presentations at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy.
The clinical poster presentations highlight the continued potent antiviral activity of ALG-000184 for chronic hepatitis B (CHB) in both HBeAg-positive and HBeAg-negative subjects.
Data from ≤72 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated sustained HBV DNA suppression (<LLOQ <10 IU/mL) in 9/10 (90%) HBeAg-positive CHB subjects with no viral breakthrough. New data also showed that as HBeAg declined to near negativity in this patient population, anti-HBe antibody (HBeAb) levels exhibited a positive trend.
Reported for the first time were antiviral and safety data in HBeAg-negative CHB subjects who received a daily single dose of 300 mg ALG-000184 monotherapy for ≤60 weeks. In all 11 subjects (100%), complete suppression of HBV DNA (<LLOQ 10 IU/mL) and RNA (<LLOQ 10 copies/mL) were noted, with reduction in HBcrAg levels indicating inhibition of HBV replication, as well as inhibition of cccDNA establishment/replenishment. In both patient populations, ALG-000184 continues to be well tolerated with no viral breakthrough.
“We designed ALG-000184 as a highly potent agent that could deliver broad antiviral efficacy in hepatitis B patients, regardless of their HBeAg status,” stated Lawrence Blatt, PhD, MBA, Chairman, President & CEO of Aligos Therapeutics. “These new data in HBeAg-negative CHB patients complement the broad antiviral activity we have already reported in HBeAg-positive CHB patients, with data now up to 72 weeks showing 90% of subjects achieved HBV DNA suppression. The extent of HBV DNA suppression observed to date in both CHB patient populations appear to exceed those reported by the current standard of care nucleos(t)ides, leading us to believe this is a best/first-in-class molecule.”
Additionally, other preclinical poster presentations demonstrate the potential of next generation siRNAs for treating metabolic dysfunction-associated steatohepatitis (MASH) and CHB as well as a novel CAM-A molecule for the treatment of CHB.
Details of the presentations are as follows:
ALG-000184: Potential best-in-class small molecule CAM-E for chronic hepatitis B (CHB)
Title: Extended Treatment of HBeAg+ CHB Subjects with the Capsid Assembly Modulator ALG-000184 with or without Entecavir is Associated with Reductions in Viral Markers and Favorable Anti-HBeAb trends
Presenter: Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong Kong
Date/Time: June 5, 2024 at 8:30am CEST
Title: Dosing with the Capsid Assembly Modulator ALG-000184 in Untreated HBeAg Negative CHB Subjects Results in Potent Antiviral Effects Including Suppression of HBV DNA/RNA and Declines in HBcrAg Levels
Presenter: Kosh Agarwal, MBBS, MRCP (UK), MD, FRCP (Ed), FRCP (London), Consultant Hepatologist and Transplant Physician, Institute of Liver Studies, King’s College Hospital NHS Foundation Trust
Time: June 5, 2024 at 8:30am CEST
Title: Association of baseline characteristics and plasma ALG-001075 to HBsAg responses in HBeAg+ CHB subjects following ALG-000184±ETV treatment
Presenter: Kha Le, PhD
Time: June 5, 2024 at 8:30am CEST
Preclinical
Title: In vitro and in vivo pharmacological characterization of human PNPLA3-targeting short interfering RNA molecules for the treatment of metabolic dysfunction-associated steatohepatitis
Presenter: Jieun Song, PhD
Time: June 6, 2024 at 8:30am CEST
Title: Second generation HBV siRNAs with novel chemistries demonstrate improved profiles compared with ALG-125755 and other clinical stage siRNAs
Presenter: Jin Hong, PhD
Date/Time: June 8, 2024 at 8:30am CEST
Title: Non-HAP CAM-A ALG-006746 and ALG-006780 induce rapid HBsAg reductions in
AAV-HBV mice and have favorable pharmacokinetic profiles
Presenter: Yannick Debing, PhD
Date/Time: June 8, 2024 at 8:30am CEST
The presentations can be found on the Scientific Presentations & Conferences section of the Aligos website (www.aligos.com) after the live event.
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 metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses.
Forward-Looking Statements
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 Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. 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, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. 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 May 7, 2024 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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