A Phase 1 Study to Evaluate Relative Bioavailability and Food Effect of an ALG-097558 Tablet Formulation and the Drug-Drug Interaction Potential of ALG-097558 and Its Metabolite ALG-097730 in Healthy Volunteers

The aim of this multi-part Phase 1 study is to evaluate the drug-drug interaction (DDI) potential of ALG-097558 via co-administration with a P-gp substrate (dabigatran) and a CYP3A4 inhibitor/P-gp inhibitor (itraconazole). In addition, this study will evaluate the relative bioavailability and food effect of a new tablet formulation for ALG-097558.
This study consists of 3 parts, all conducted in healthy volunteers (HV). Study Parts A and B are designed to assess the perpetrator or victim DDI risk of ALG-097558 mediated by CYP/P-gp interactions in healthy adult subjects. Part A will evaluate the potential impact of itraconazole, a CYP3A potent inhibitor, while Part B will investigate the potential impact of ALG-097558 (perpetrator) on dabigatran etexilate, a P-gp transporter substrate. Study Part C is designed to study the bioavailability of a new formulation of the ALG-097558 tablet and the food effect on this tablet.
This study has one primary objective for each part of the study. For Part A: to evaluate the effect of a CYP3A4 inhibitor/Pg-p inhibitor, itraconazole, on the pharmacokinetics (PK) of ALG-097558 and the metabolite, ALG-097730. For Part B: to evaluate the effect of multiple doses of ALG-097558 on the pharmacokinetics of a P-gp substrate, dabigatran. For Part C: to evaluate the relative bioavailability of 2 different tablet formulations of ALG-097558 and effect of food on the pharmacokinetics of ALG-097558 and the metabolite, ALG-097730.

Start Date13 May 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT06698549

/ CompletedPhase 1

A Phase 1 Non-Randomized, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in Healthy Subjects With Normal Renal Function

This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with severe renal impairment and subjects without renal impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characterize the effect of renal impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.

Start Date20 Feb 2025

Sponsor / Collaborator

Aligos Therapeutics, Inc.

[+1]

NCT06568861

/ CompletedPhase 1

A Phase 1 Non-Randomized, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function

This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characterize the effect of hepatic impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.

Start Date13 Jan 2025

Sponsor / Collaborator

Aligos Therapeutics, Inc.

[+1]

100 Clinical Results associated with ALG-097558

100 Translational Medicine associated with ALG-097558

100 Patents (Medical) associated with ALG-097558

Literatures (Medical) associated with ALG-097558

10 Jul 2025·JOURNAL OF MEDICINAL CHEMISTRY

Discovery and Preclinical Profile of ALG-097558, a Pan-Coronavirus 3CLpro Inhibitor

Article

Author: Beigelman, Leonid ; Stoycheva, Antitsa D. ; Chang, Sandra ; Chanda, Sushmita ; De Jonghe, Steven ; Smith, David B. ; Serebryany, Vladimir ; Hu, Haiyang ; Jekle, Andreas ; Laporte, Manon ; Wuyts, Jurgen ; Liu, Cheng ; Ren, Suping ; Le, Kha ; Zhang, Peng ; Vandyck, Koen ; Baloju, Vamshi ; Jochmans, Dirk ; Welch, Michael ; Chaltin, Patrick ; Marchand, Arnaud ; Maskos, Klaus ; Deval, Jerome ; Leyssen, Pieter ; Neyts, Johan ; Abdelnabi, Rana ; Boland, Sandro ; Raboisson, Pierre ; Lin, Tse-I ; Tauchert, Marcel J. ; Anugu, Sreenivasa ; Bardiot, Dorothée ; McGowan, David C. ; Blatt, Lawrence ; Deta, Kiran ; Jaisinghani, Ruchika ; Symons, Julian A. ; Gupta, Kusum ; Stevens, Sarah ; Faucher, Marine O.

The SARS-CoV-2 outbreak of 2019 had a devastating impact on global health and economies worldwide. The viral cysteine protease (3CLpro) is responsible for viral polypeptide bond cleavages and is therefore an essential target to inhibit viral replication. Here, we report the discovery of an orally available, reversible covalent inhibitor of the SARS-CoV-2 main protease that is also highly active across other human coronaviruses and demonstrated oral efficacy in a Syrian hamster infection model at low plasma concentrations. Projection of pharmacokinetics (PK) in humans, based on PK studies in preclinical species and enhanced in vitro/in vivo efficacy of ALG-097558 (7) indicated the potential for BID dosing without the need for ritonavir, the PK boosting component of Paxlovid. After preclinical safety and pharmacological studies, ALG-097558 has progressed to phase 1 clinical trials.

News (Medical) associated with ALG-097558

23 Feb 2026

·www.biospace.com

Aligos Therapeutics Presents Positive Data at the Conference on Retroviruses and Opportunistic Infections (CROI)

SOUTH SAN FRANCISCO, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced positive data from two presentations at the Conference on Retroviruses and Opportunistic Infections (CROI), being held February 22 – 25, 2026 in Denver, Colorado. The pevifoscorvir sodium presentation highlights the Phase 1 monotherapy study of pevifoscorvir sodium, a potent CAM-E under development for the treatment of chronic hepatitis B virus (HBV) infection. Additionally, the ALG-097558 presentation showcases data from participants with hepatic and renal impairment. The ALG-097558 project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), under Contract No. 75N93023C00052. “We are pleased to continue showcasing the best/first-in-class pevifoscorvir sodium data from the Phase 1 study in participants with chronic HBV infection,” said Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and CEO of Aligos Therapeutics. “Additionally, we continue to move our COVID program forward with grants from government agencies and are pleased to show some of this important clinical work at CROI this year.” Details of the presentations are as follows: Pevifoscorvir sodium: Potential first-/best-in-class small molecule CAM-E under investigation for chronic hepatitis B virus (HBV) infection Poster #: 588 Title: High Viral Suppression in Chronic HBV Infection Subjects with Pevifoscorvir Sodium Monotherapy Presenter: Stanley Wang, MD Date/Time: February 23, 2026, 2:30pm – 4:00pm MST Session: Beyond the C: Hepatitis D, B, and E ALG-097558: Potential best-in-class ritonavir-free small molecule pan-coronavirus protease inhibitor Poster #: 737 Title: Pharmacokinetics of ALG-097558, a Pan-Coronavirus 3CL-Pro Inhibitor, in Renal and Hepatic Impairment Presenter: Megan Fitzgerald, PhD Date/Time: February 25, 2026, 2:30pm – 4:00pm MST Session: SARS-CoV-2 Therapy, Consequences, and Outcomes The presentations can be found on the Posters & Presentations section of the Aligos website ( ) after the live event. About Aligos Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biotechnology company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for high unmet medical needs such as chronic hepatitis B virus (HBV) infection, obesity, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses. For more information, please visit or follow us on LinkedIn or X. 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 November 6, 2025 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. Investor Contact Aligos Therapeutics, Inc. Jordyn Tarazi Vice President, Investor Relations & Corporate Communications +1 (650) 910-0427 jtarazi@aligos.com Media Contact Inizio Evoke Jake Robison Vice President Jake.Robison@inizioevoke.com

Phase 1Clinical Result

06 Aug 2025

·investor.aligos.com

Aligos Therapeutics Reports Recent Business Progress and Second Quarter 2025 Financial Results

SOUTH SAN FRANCISCO, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today reported recent business progress and financial results for the second quarter 2025. “Initiation of the Phase 2 B-SUPREME study of ALG-000184 is well underway with regulatory approvals across a number of countries, including the US, China, Canada, Taiwan, UK, New Zealand, and Moldova,” stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “Site activations are in progress, subjects are being screened, and we expect dosing to commence in the coming weeks. This pertinent study is the next step in our journey to potentially deliver better therapies for patients living with HBV infection and create value for our stakeholders. The Phase 1 data showcasing 96 weeks of treatment presented at the EASL meeting suggests that ALG-000184 has the potential to replace standard of care treatment for chronic suppression of HBV infection and may become the backbone of treatments aimed at a functional cure. We remain excited about the potential of ALG-000184 and the entirety of our pipeline, including ALG-055009 which remains in discussions with potential partners.” Recent Business Progress Pipeline Updates ALG-000184: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection The Phase 2 B-SUPREME study (NCT04746183) of ALG-000184 in subjects with chronic HBV infection recently began obtaining regulatory approvals, activating global sites, and screening subjects. Dosing is expected to commence in the coming weeks. The study is designed as a randomized, double-blind, active-controlled multicenter study evaluating the safety and efficacy of ALG-000184 monotherapy compared with tenofovir disoproxil fumarate in approximately 200 untreated HBeAg+ and HBeAg- adult subjects with chronic HBV infection for 48 weeks. The primary endpoint in the HBeAg+ part will be HBV DNA

Clinical ResultPhase 1Phase 2Financial Statement

06 May 2025

·www.globenewswire.com

Aligos Therapeutics Reports Recent Business Progress and First Quarter 2025 Financial Results

SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today reported recent business progress and financial results for the first quarter 2025. “We continued to make progress towards our corporate development plans aimed at advancing life-saving therapies for viral and liver diseases,” stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “Over the past few months, we raised over $100M to begin our important Phase 2 study of ALG-000184 in chronic hepatitis B virus infection and we are on track to begin dosing by mid-2025 following recent positive correspondence with the FDA. Our data presentation at the APASL meeting showcased the extension of dosing to 96 weeks. These data continue to support our belief that ALG-000184 has the potential to be first line standard of care treatment for chronic suppression of HBV infection as well as the drug of choice to combine with other agents aimed at functional cure. Additionally, recent data presented at the APASL meeting for ALG-055009, our THR-β agonist for the treatment of MASH, further demonstrated best-in-class potential. We are continuing our partnering discussions for ALG-055009 with several multinational pharmaceutical companies that have strong interests in MASH and other metabolic diseases.” Recent Business Progress Pipeline Updates ALG-000184: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection 96-week dosing recently completed in the Phase 1 study and data readouts are planned for scientific conferences this yearInterim data from up to 96 weeks following an oral daily dose of 300 mg ALG-000184 in both HBeAg+ and HBeAg- subjects with chronic HBV infection were presented at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2025 ALG-000184 administered for up to 96 weeks was well tolerated, exhibited a favorable PK profile, and demonstrated potentially best-in-class antiviral activityData from ≤84 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated sustained HBV DNA suppression (

Clinical ResultPhase 2Phase 1Financial Statement

100 Deals associated with ALG-097558

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	South Africa	The University of Liverpool	03 Jul 2020
COVID-19	Phase 2	United Kingdom	The University of Liverpool	03 Jul 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06698549 (CTgov)	Phase 1	COVID-19	12	ALG-097558 (Subjects With Severe Renal Impairment)	vnyvxgncoy(vizjwahjzr) = pxqrvyvqut obsbacxknq (pcpevmydjs, 71.6) View more	-	09 Jul 2026
				ALG-097558 (Subjects With Normal Renal Function)	vnyvxgncoy(vizjwahjzr) = tdfplokgnb obsbacxknq (pcpevmydjs, 34.4) View more

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