A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg-Negative Adult Subjects With Chronic Hepatitis B Virus Infection (B-SUPREME)

This is a Phase 2 study to evaluate efficacy and safety of 48 weeks of oral once daily monotherapy with ALG-000184 versus tenofovir disproxil fumarate (TDF) for chronic HBV infection.

Start Date15 Jul 2025

Sponsor / Collaborator

ALIGOS THERAPEUTICS INC

NCT06959888

/ CompletedPhase 1

A Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of ALG-055009 Formulations

This is a phase 1 single dose, open-label, randomized, two-period, two-sequence, crossover study of ALG-055009 conducted in 1 cohort of healthy volunteers. The primary purpose of this study is to compare the single-dose pharmacokinetics of the 0.7 mg dose level of 2 types of soft gelatin capsule formulations of ALG-055009, Formulation 1 and Formulation 2, in approximately 8 healthy volunteers.

Start Date25 Mar 2025

Sponsor / Collaborator

ALIGOS THERAPEUTICS INC

NCT06698549

/ RecruitingPhase 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 Date01 Feb 2025

Sponsor / Collaborator

ALIGOS THERAPEUTICS INC

[+1]

100 Clinical Results associated with ALIGOS THERAPEUTICS INC

0 Patents (Medical) associated with ALIGOS THERAPEUTICS INC

Literatures (Medical) associated with ALIGOS THERAPEUTICS INC

01 Aug 2025·ANTIVIRAL RESEARCH

Antisense oligonucleotides as drugs with both direct and indirect antiviral actions

Review

Author: Rajwanshi, Vivek K ; Hong, Jin

In this review, we provide a historical and current guide of recent advances in the development of ASOs either targeting viruses directly, or indirectly through modulation of host factors. Although preclinical and discovery assets are mentioned in this review, more extensive coverage is given to clinical stage assets. Most of these clinical assets are currently concentrated in the fight to eradicate hepatitis B virus (HBV), and hepatitis C virus (HCV). Progresses have also been made in extrahepatic delivery of oligonucleotides and the possibility of treating respiratory virus infections in lungs with ASOs would be feasible.

10 Jul 2025·JOURNAL OF MEDICINAL CHEMISTRY

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

Article

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

01 Jun 2025·Nucleic Acid Therapeutics

Developmental and Reproductive Toxicity Testing Strategies for Oligonucleotides: A Workshop Proceedings

Review

Author: White, Tacey ; Hoberman, Alan ; Chen, Connie L. ; Maki, Kazushige ; Coder, Pragati S. ; Kim, Tae-Won ; Bender, Sara M. ; Blasi, Eileen ; Matsumoto, Mineo ; Powles-Glover, Nicola ; Siezen, Christine ; Misner, Dinah L. ; Saffarini, Camelia ; Cavagnaro, Joy A. ; Mueller, Lutz ; Duijndam, Britt ; Leconte, Isabelle ; Rayhon, Stephanie ; Mikashima, Fumito ; Bowman, Christopher J. ; Hannas, Bethany R. ; Wange, Ronald L. ; Templin, Michael V. ; Sisler, Jennifer

A 2023 workshop brought together stakeholders involved in the development and safety assessment of oligonucleotide (ONT) therapeutics. The purpose was to discuss potential strategies and opportunities for enhancing developmental and reproductive toxicity (DART) assessment of ONTs. The workshop was timely, bringing together regulators, industry representatives, consultants, and contract research organization partners interested in the ongoing development of internationally harmonized guidance for nonclinical safety assessment of ONTs. Given DART's importance in nonclinical safety assessment and the unique attributes of ONTs, the forum discussed case studies, consensus approaches, and areas needing further development to optimize DART strategies. This report covers the workshop proceedings, highlighting methods to achieve a robust DART assessment for ONTs. It includes case studies that described strategies for dose level selection, dosing frequency, species selection, and alternative animal model approaches. Topics also cover surrogate ONT use, exposure of the placenta and embryo/fetal compartment, and weight of evidence approaches. A goal of these workshop proceedings is to describe example approaches to hopefully inform the DART strategy expectations in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidance currently under development for nonclinical safety assessment of ONTs.

148

News (Medical) associated with ALIGOS THERAPEUTICS INC

13 Aug 2025

·pipelinereview.com

Aligos Therapeutics Announces First Subject Dosed in the Phase 2 B-SUPREME Study of ALG-000184 in Subjects with Chronic HBV Infection

SOUTH SAN FRANCISCO, CA, USA I August 13, 2025 I Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that dosing in the Phase 2 B-SUPREME study of its investigational compound ALG-000184 has been initiated in subjects with chronic hepatitis B virus (HBV) infection. “Despite available treatments for chronic HBV infection, better therapies are needed to stem the progression to end-stage liver disease and liver cancer,” said Nezam Afdhal, MD, DSc, Chief of Gastroenterology, Hepatology, and Nutrition at Beth Israel Deaconess Medical Center and Charlotte & Irving Rabb Distinguished Professor of Medicine at Harvard Medical School. “I am pleased that therapies such as Aligos’ ALG-000184 are continuing to progress. The impressive antiviral activity seen in clinical trials to date provides hope for patients in need.” “Dosing the first subjects in our Phase 2 B-SUPREME study is an important milestone for Aligos,” said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “We are pleased by the engagement of the clinicians and subjects, as they recognize the need for improved treatment regimens for chronic HBV infection. We believe that ALG-000184 has first/best-in-class potential based on the exciting data seen across viral markers of HBV to date. We look forward to continuing to advance ALG-000184 for patients in need of better outcomes.” The Phase 2 B-SUPREME study (NCT06963710) is 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

Phase 2Phase 1Clinical ResultVaccine

13 Aug 2025

·investor.aligos.com

Aligos Therapeutics Announces First Subject Dosed in the Phase 2 B-SUPREME Study of ALG-000184 in Subjects with Chronic HBV Infection

SOUTH SAN FRANCISCO, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that dosing in the Phase 2 B-SUPREME study of its investigational compound ALG-000184 has been initiated in subjects with chronic hepatitis B virus (HBV) infection. “Despite available treatments for chronic HBV infection, better therapies are needed to stem the progression to end-stage liver disease and liver cancer,” said Nezam Afdhal, MD, DSc, Chief of Gastroenterology, Hepatology, and Nutrition at Beth Israel Deaconess Medical Center and Charlotte & Irving Rabb Distinguished Professor of Medicine at Harvard Medical School. “I am pleased that therapies such as Aligos’ ALG-000184 are continuing to progress. The impressive antiviral activity seen in clinical trials to date provides hope for patients in need.” “Dosing the first subjects in our Phase 2 B-SUPREME study is an important milestone for Aligos,” said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “We are pleased by the engagement of the clinicians and subjects, as they recognize the need for improved treatment regimens for chronic HBV infection. We believe that ALG-000184 has first/best-in-class potential based on the exciting data seen across viral markers of HBV to date. We look forward to continuing to advance ALG-000184 for patients in need of better outcomes.” The Phase 2 B-SUPREME study (NCT06963710) is 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

Phase 2Phase 1Clinical ResultVaccine

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

100 Deals associated with ALIGOS THERAPEUTICS INC

100 Translational Medicine associated with ALIGOS THERAPEUTICS INC

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Pipeline

Pipeline Snapshot as of 05 Oct 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 1

Phase 2

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

ALG-000184 ( HBV capsid )	Hepatitis B, Chronic More	Phase 2
ALG-055009 ( THR-β )	Nonalcoholic Steatohepatitis More	Phase 2
ALG-097558 ( SARS-CoV-2 3CLpro )	COVID-19 More	Phase 2
ALG-010133 ( L-HBsAg )	Hepatitis B, Chronic More	Phase 1
ALG-020575 ( HBV RNA )	Hepatitis B More	Phase 1

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