Aligos Therapeutics Presents Clinical Data from NASH Program at the 2023 Paris Hepatology Conference

Rhea-AI Summary

Aligos Therapeutics (Nasdaq: ALGS) showcased positive results for its thyroid receptor-beta agonist candidate, ALG-055009, during the 15th Paris Hepatology Conference from March 27-29, 2023. The Phase 1 data revealed a favorable safety and pharmacokinetic profile in healthy volunteers and subjects with hyperlipidemia. The study demonstrated low variability and similar bioavailability for both liquid and gelcap formulations, which are set for a Phase 2 study with a regulatory filing anticipated in Q4 2023. These results indicate promising potential for addressing unmet medical needs in liver and viral diseases.

Positive

• Demonstrated favorable safety and pharmacokinetic profile of ALG-055009.
• Low variability and similar bioavailability for liquid and gelcap formulations.
• Phase 2 study set to begin with regulatory filing expected in Q4 2023.

Negative

• None.

SOUTH SAN FRANCISCO, Calif., March 29, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that the company presented Phase 1 data for its thyroid receptor-beta (THR-ß) agonist candidate, ALG-055009, at the 15^th Paris Hepatology Conference, taking place virtually March 27 – 29, 2023. The presentation will be available on the Scientific Presentations and Conferences page on Aligos’ corporate website following the meeting.

“We’re pleased to show at the conference that ALG-055009 has demonstrated a favorable safety and pharmacokinetic profile in healthy volunteers and subjects with hyperlipidemia,” said Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics. “Additionally, we also showed that, like the liquid formulation in earlier Phase 1 cohorts, the gelcap formulation had low variability and similar bioavailability and is well suited for use in the upcoming Phase 2 study. That study remains on track for a Q4 2023 regulatory filing.”

Presentation title: The THR-beta Agonist ALG-055009 Has a Favorable Safety and Pharmacokinetic Profile and Dose Proportionally Lowers Lipid Biomarkers in a Phase 1 Study
Presenter: Matthew W. McClure, M.D., Chief Medical Officer, Aligos Therapeutics
Presentation date: Wednesday, March 29, 2023
Presentation time: 15:55 – 16:40 CEST/10:55 – 11:40 a.m. ET
Session title: R&D 2: The Drugs Pipeline Presented by Companies
Summary: Data from the ongoing Phase 1 study ALG-055009-301 (NCT05090111) show that single ALG-055009 doses of up of 4 mg and multiple doses of up to 1 mg daily for 14 days were well tolerated in healthy volunteers and subjects with hyperlipidemia. ALG-055009 also showed favorable pharmacokinetic parameters after single and multiple doses, including dose-proportional increases in exposure for the liquid formulation and similar pharmacokinetic profiles for liquid and gelcap formulations of ALG-055009. Expected thyromimetic effects were also observed, including dose-proportional reductions in atherogenic lipids.

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 nonalcoholic steatohepatitis (NASH) and viruses with high unmet medical need such as coronaviruses and chronic hepatitis B (CHB).

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, the statements that the gelcap formulation of ALG-055009 is well suited for use in the upcoming Phase 2 study and that such study remains on track for a Q4 2023 regulatory filing. 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’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 9, 2023 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.

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 are the Phase 1 results for ALG-055009 from Aligos Therapeutics?

The Phase 1 results indicated a favorable safety and pharmacokinetic profile for ALG-055009, well tolerated in healthy volunteers and subjects with hyperlipidemia.

When is the Phase 2 study for ALG-055009 expected to be filed?

The regulatory filing for the Phase 2 study of ALG-055009 is anticipated in Q4 2023.

What condition is ALG-055009 targeting?

ALG-055009 is developed to address unmet medical needs in liver diseases and hyperlipidemia.

What formulations of ALG-055009 were tested in Phase 1?

Both liquid and gelcap formulations of ALG-055009 were tested, showing low variability and similar bioavailability.

Where was the Phase 1 data for ALG-055009 presented?

The Phase 1 data was presented at the 15th Paris Hepatology Conference held virtually from March 27 to March 29, 2023.