Aligos Therapeutics Presents Positive Clinical Data at APASL 2024 from ALG-055009 and ALG-000184 Phase 1 Studies

2024-03-27

临床1期临床结果临床2期

SOUTH SAN FRANCISCO, Calif., March 27, 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 three oral presentations and one poster presentation at the 33rd Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2024, being held March 27-31, 2024 in Kyoto, Japan.

The poster presentation highlights ALG-055009 Phase 1 data that showed multiple-ascending doses (MAD) over 14 days in hyperlipidemic subjects produced favorable, dose-dependent pharmacodynamic effects on atherogenic lipids and sex hormone binding globulin (SHBG), an indicator of target engagement in the liver.

The three oral presentations provide interim data from Parts 3 and 4 of Aligos’ ALG-000184 Phase 1 extended dosing study showing consistent, potent antiviral activity across different cohorts of untreated CHB patients receiving once daily doses of ALG-000184 as monotherapy or in combination with entecavir (ETV).

“We are pleased to present these additional Phase 1 data for ALG-055009 and ALG-000184 at APASL 2024. After the recent initiation of our Phase 2a HERALD study of ALG-055009 in MASH subjects, we remain encouraged by the data presented showing a favorable safety profile and strong evidence of target engagement, as shown by induction of sex hormone binding globulin and lowering of atherogenic lipids. We continue to believe our molecule has the potential to be best-in-class,” said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “In addition, the three ALG-000184 oral presentations demonstrate a consistent effect in the reduction of key viral markers. These promising results affirm our belief that this compound will play an essential role in the future treatment of hepatitis B.”

Details of the presentations are as follows:

ALG-055009: Potential best-in-class small molecule THR-β agonist THR-β agonist for metabolic dysfunction-associated steatohepatitis (MASH)

Poster Presentation Title: Pharmacodynamics of Multiple Ascending Oral Doses of ALG-055009, a THR-β Agonist THR-β Agonist, in Hyperlipidemic Subjects

Presented by Megan Fitzgerald, Ph.D.

March 28, 2024 at 5:10pm GMT+9

ALG-000184: Potential best-in-class small molecule CAM-E for chronic hepatitis B (CHB)

Oral Presentation Title: ALG-000184 (300mg) ± Entecavir Results in Substantial HBV Antigen Declines in Untreated HBeAg-Positive Subjects with CHB

Presented by Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong Kong

March 28, 2024 at 9:30am GMT+9

Oral Presentation Title: ALG-000184 (100 mg) + ETV Leads to Stronger Antiviral Effects Compared to ETV Alone in HBeAg-Positive CHB

Presented by Professor Jinlin Hou, MD, Director and Professor of the Hepatology Unit and Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

March 28, 2024 at 9:48am GMT+9

Oral Presentation Title: ALG-000184 Has Favorable Antiviral Effect & Safety in Untreated Asian/Non-Asian HBeAg-Negative CHB Subjects

Presented by Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong Kong

March 28, 2024 at 9:57am GMT+9

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 chronic hepatitis B (CHB) and coronaviruses.

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, with respect to ALG-055009, statements that the company remains encouraged by the data presented showing a favorable safety profile and strong evidence of target engagement and continues to believe the molecule has the potential to be best-in-class; and with respect to ALG-000184, statements around the promising results contained in the three oral presentations demonstrating consistent effect in the reduction of key viral models, which results affirm the company’s belief that this compound will play an essential role in the future treatment of hepatitis B. 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, and the impact of global events and other macroeconomic conditions on the Aligos business. 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 12, 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.

Contacts

Company

Jordyn Tarazi

Vice President, Investor Relations & Corporate Communications

(650) 910-0427

jtarazi@Aligos.com

Media

Michael Fitzhugh

LifeSci Communications

(628) 234-3889

mfitzhugh@lifescicomms.com