Aligos Therapeutics Presents Data for its Chronic Hepatitis B Drug Candidates at the 30th Annual Conference of the Asian Pacific Association for the Study of the Liver

Rhea-AI Summary

Aligos Therapeutics (Nasdaq: ALGS) will present four posters at the 30th Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL) from February 4-6, 2021. The presentations will showcase progress in their chronic hepatitis B (CHB) drug candidates, ALG-010133 and ALG-000184, currently in Phase 1a/b studies. Notable findings include ALG-010133's promising preclinical efficacy and pharmacokinetics, and ALG-000184's safety and tolerability data. These trials aim to develop effective combination therapies against CHB.

Positive

• Successful Phase 1a/b trials for two lead drug candidates aimed at chronic hepatitis B.
• ALG-010133 demonstrated high efficacy and favorable pharmacokinetic profile in preclinical studies.
• ALG-000184 showed safety and tolerability at single doses up to 500 mg in healthy volunteers, supporting further clinical evaluations.

Negative

• None.

SOUTH SAN FRANCISCO, Calif., Feb. 03, 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 will deliver four poster presentations at the 30^th Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL), taking place virtually from February 4 through February 6, 2021.

“We are proud to show progress for two of our clinical candidates from our chronic hepatitis B portfolio,” said Aligos CEO Lawrence Blatt, Ph.D., MBA. “Both candidates are currently being evaluated in Phase 1a/b umbrella studies where we will evaluate each for antiviral activity in CHB patients following demonstration of safety and tolerability in healthy volunteers. These trials are part of a larger plan to develop highly effective treatments using combinations of multiple novel drugs from our portfolio. We look forward to advancing our other lead candidates targeting other viral mechanisms of action into the clinic alongside ALG-010133 and ALG-000184.”

Three of the presentations highlight encouraging data from Aligos’ two most advanced CHB candidates for development toward a combination therapy for chronic hepatitis B (CHB): STOPS™ (ALG-010133), a proprietary oligonucleotide designed to inhibit hepatitis B virus (HBV) S-antigen (or HBsAg) replication, and ALG-000184, a capsid assembly modulator (CAM), designed to inhibit HBV replication.

The first presentation, titled “Preclinical Efficacy and Pharmacokinetics of ALG-010133, an S-Antigen Transport-inhibiting Oligonucleotide Polymers (STOPS) for the Treatment of Chronic Hepatitis B (CHB)”, demonstrated that Aligos’ lead STOPS candidate inhibited S-antigen release from cells in several lines of human hepatocytes. In vivo, ALG-010133 demonstrated high, rapid and sustained exposure in the liver following single subcutaneous injections given to nonclinical species, predicting once-weekly dosing in humans. Further, a nonclinical multiple dosing study in which animals were given three weekly subcutaneous doses demonstrated sufficient concentrations in the liver sufficient for projected efficacy in human CHB patients. Together, the combination of excellent in vitro efficacy and a favorable pharmacokinetic profile in vivo has justified ALG-010133’s progression to a Phase 1a/b trial for evaluation as a potential treatment for CHB.

A second presentation, “Safety, tolerability and pharmacokinetics of single ascending doses of ALG-000184, a Class II Capsid Assembly Modulator for the treatment of Chronic Hepatitis B (CHB), in healthy volunteers (HV)”, outlined preliminary data supporting further evaluation of Aligos’ small molecule candidate ALG-000184 in healthy volunteers and in CHB patients, as planned in the ongoing Phase 1a/b trial. At single oral doses of up to 500 mg, ALG-000184 was safe, well-tolerated and demonstrated a linear pharmacokinetic profile supporting once-daily oral dosing. Doses of 100 mg or higher resulted in plasma concentrations of active compound that are projected to result in antiviral activity in CHB patients.

Two other poster presentations entitled “Excellent preclinical characteristics of ALG-000184, a prodrug of the HBV capsid assembly modulator ALG-001075” and “ALG-020572, a next generation hepatitis B virus (HBV) antisense oligonucleotide (ASO) with bridged nucleic acid chemistry, has a significantly improved preclinical profile” highlight the nonclinical characteristics of ALG-000184 and its parent compound, ALG-001075, and ALG-020572, Aligos’ ASO candidate for chronic hepatitis B that significantly improves upon other ASOs in terms of nonclinical safety and efficacy.

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 workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

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 our plan to evaluate each of our clinical candidates for antiviral activity in CHB patients following demonstration of safety and tolerability in healthy volunteers; our plan to develop highly effective treatments using combinations of multiple novel drugs from our portfolio; our advancing our other lead candidates targeting other viral mechanisms of action into the clinic alongside ALG-010133 and ALG-000184; ALG-010133’s progression to a Phase 1a/b trial for evaluation as a potential treatment for CHB following excellent in vitro efficacy and a favorable pharmacokinetic profile in vivo; and further evaluation of Aligos’ small molecule candidate ALG-000184 in healthy volunteers and in CHB patients as planned in the ongoing Phase 1a/b trial. 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.

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com 

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com 

FAQ

What is the significance of Aligos Therapeutics' presentations at APASL 2021?

Aligos Therapeutics will highlight the progress of their chronic hepatitis B drug candidates, ALG-010133 and ALG-000184, at APASL 2021, showcasing key data that could influence their development.

What are the main findings from Aligos Therapeutics' clinical trials?

The trials revealed promising efficacy, safety, and pharmacokinetics for ALG-010133 and ALG-000184, indicating potential for effective treatments against chronic hepatitis B.

When are Aligos Therapeutics' clinical trials for chronic hepatitis B expected to advance?

The trials for both ALG-010133 and ALG-000184 are ongoing, with evaluations planned to assess their effectiveness in CHB patients following safety demonstrations.

What is ALG-010133 and its role in hepatitis B treatment?

ALG-010133 is an oligonucleotide designed to inhibit HBV S-antigen replication, showing strong preclinical efficacy and pharmacokinetics, leading to its progression to Phase 1a/b trials.

How is ALG-000184 expected to perform in clinical trials?

ALG-000184 is a capsid assembly modulator that has shown safety and a linear pharmacokinetic profile in early trials, supporting further investigation in CHB patients.