Aligos Therapeutics Announces First Subject Dosed in the Phase 2 B-SUPREME Study of ALG-000184 in Subjects with Chronic HBV Infection
Aligos Therapeutics (Nasdaq: ALGS) has initiated dosing in its Phase 2 B-SUPREME study of ALG-000184 for chronic hepatitis B virus (HBV) infection treatment. The study will evaluate 200 untreated subjects over 48 weeks, comparing ALG-000184 monotherapy to tenofovir disoproxil fumarate.
The randomized, double-blind study will assess both HBeAg+ and HBeAg- adult subjects, with primary endpoints focusing on HBV DNA levels. The trial will also evaluate safety, pharmacokinetics, and various biomarkers. Interim data is expected in 2026, with topline results anticipated in 2027.
Aligos Therapeutics (Nasdaq: ALGS) ha iniziato la somministrazione nella sua fase 2 B-SUPREME di ALG-000184 per il trattamento dell'epatite cronica B (HBV). Lo studio valuterà 200 soggetti non trattati per 48 settimane, confrontando la monoterapia con ALG-000184 con il tenofovir disoproxil fumarato.
Lo studio randomizzato e in doppio cieco includerà adulti HBeAg+ e HBeAg-, con endpoint primari incentrati sui livelli di HBV DNA. La sperimentazione valuterà anche sicurezza, farmacocinetica e vari biomarcatori. I dati intermedi sono previsti nel 2026, con risultati topline attesi nel 2027.
Aligos Therapeutics (Nasdaq: ALGS) ha iniciado la administración en su estudio de fase 2 B-SUPREME de ALG-000184 para el tratamiento de la hepatitis B crónica (VHB). El estudio evaluará a 200 sujetos no tratados durante 48 semanas, comparando la monoterapia con ALG-000184 frente a tenofovir disoproxil fumarato.
El estudio aleatorizado y doble ciego incluirá adultos HBeAg+ y HBeAg-, con puntos finales primarios centrados en los niveles de ADN del VHB. El ensayo también evaluará seguridad, farmacocinética y diversos biomarcadores. Se esperan datos intermedios en 2026, y los resultados principales están previstos para 2027.
Aligos Therapeutics (Nasdaq: ALGS)는 만성 B형간염(HBV) 치료를 위한 ALG-000184의 임상 2상 B-SUPREME 연구에서 투약을 시작했습니다. 이 연구는 치료받지 않은 200명을 48주 동안 평가하며 ALG-000184 단독요법을 테노포비르 디소프록실 푸마레이트와 비교합니다.
무작위 배정, 이중맹검 방식의 이 연구는 HBeAg 양성 및 음성 성인 대상자를 포함하며 주요 평가변수는 HBV DNA 수치에 중점을 둡니다. 또한 안전성, 약동학 및 다양한 바이오마커도 평가합니다. 중간 데이터는 2026년에 예정되어 있고, 톱라인 결과는 2027년에 예상됩니다.
Aligos Therapeutics (Nasdaq : ALGS) a commencé l'administration dans son essai de phase 2 B-SUPREME de ALG-000184 pour le traitement de l'hépatite B chronique (VHB). L'étude évaluera 200 sujets non traités sur 48 semaines, comparant la monothérapie ALG-000184 au fumarate de ténofovir disoproxil.
L'essai randomisé en double aveugle inclura des adultes HBeAg+ et HBeAg-, avec des critères principaux axés sur les niveaux d'ADN du VHB. L'étude évaluera également la sécurité, la pharmacocinétique et divers biomarqueurs. Des données intermédiaires sont attendues en 2026, et les résultats principaux sont prévus en 2027.
Aligos Therapeutics (Nasdaq: ALGS) hat mit der Dosierung in der Phase-2-Studie B-SUPREME von ALG-000184 zur Behandlung der chronischen Hepatitis-B-Virus (HBV)-Infektion begonnen. Die Studie wird 200 unbehandelte Probanden über 48 Wochen untersuchen und ALG-000184-Monotherapie mit Tenofovir-Disoproxilfumarat vergleichen.
Die randomisierte, doppelblinde Studie wird erwachsene HBeAg+ und HBeAg- Teilnehmer einschließen; die primären Endpunkte konzentrieren sich auf HBV-DNA-Spiegel. Außerdem werden Sicherheit, Pharmakokinetik und verschiedene Biomarker evaluiert. Zwischendaten werden für 2026 erwartet, mit Topline-Ergebnissen voraussichtlich 2027.
- Progression to Phase 2 trial indicates promising development of ALG-000184
- Previous clinical trials showed impressive antiviral activity
- Large-scale study with 200 subjects strengthens statistical significance
- Potential first/best-in-class therapy for chronic HBV infection
- Long timeline with topline data not expected until 2027
- Competitive market with existing HBV treatments already available
Insights
Aligos' Phase 2 trial initiation for HBV drug ALG-000184 marks significant clinical advancement with potential first/best-in-class profile.
Aligos Therapeutics has reached a significant milestone with the initiation of dosing in their Phase 2 B-SUPREME study for ALG-000184, targeting chronic hepatitis B virus (HBV) infection. The study design reveals a robust clinical trial that will enroll approximately 200 untreated subjects with both HBeAg+ and HBeAg- chronic HBV infection, comparing the investigational compound directly against tenofovir disoproxil fumarate, a current standard of care.
The trial's primary endpoints are strategically designed to demonstrate ALG-000184's efficacy in viral suppression, with HBV DNA levels below the lower limit of quantification as the key measure. What's particularly notable is the 48-week treatment duration, which will provide substantial data on both safety and sustained efficacy.
The company's assertion of "first/best-in-class potential" is supported by references to "impressive antiviral activity" and "exciting data seen across viral markers" in earlier studies. This suggests the compound may offer advantages over existing therapies in a disease area where medical need remains high despite available treatments. Current HBV treatments typically suppress viral replication but rarely lead to functional cure, making novel mechanisms of action critically important.
With interim data projected for 2026 and topline results in 2027, this represents a mid-term catalyst for Aligos. The involvement of prominent hepatology experts like Dr. Nezam Afdhal lends credibility to the program and indicates significant interest from key opinion leaders in the field.
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 <LLOQ (10 IU/mL, target detected [TD] or target not detected [TND]) and the primary endpoint in the HBeAg- part will be HBV DNA <LLOQ (10 IU/mL, target not detected [TND]). The study will also evaluate the safety, pharmacokinetics, and other secondary and exploratory biomarkers, including reductions in HBV antigens and other markers of HBV infection. Interim data is projected in 2026, and topline data is anticipated in 2027.
About ALG-000184
ALG-000184 was derived from initial IP licensed from the laboratory of Dr. Raymond Schinazi at Emory University, which was further optimized by Aligos. ALG-000184 is a potent potential best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for chronic hepatitis B virus (HBV) infection. Phase 1 studies have demonstrated after single and multiple daily doses that ALG-000184 was well-tolerated by study participants, with no safety signals observed, and demonstrated linear PK and excellent antiviral activity. In longer term Phase 1 studies, ALG-000184 300mg QD x ≤96 weeks ± entecavir (ETV) and ALG-000184 monotherapy have demonstrated sustained reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. ALG-000184 has a regulatory path, as acknowledged by the FDA, EMA, and NMPA (China), for subsequent studies utilizing the chronic suppressive pathway. Phase 1 96-week dosing of ALG-000184 has been completed with the final and post-treatment follow up data expected at the American Association for the Study of Liver Disease’s The Liver Meeting® in 2025. The Phase 2 B-SUPREME study initiated in August 2025, with interim data projected in 2026, and topline data anticipated in 2027.
About Chronic HBV Infection
Chronic hepatitis B virus (HBV) infection is a life-threatening viral infection that primarily affects the liver with 254 million patients worldwide and approximately 1.2 million individuals become newly infected every year despite the availability of a prophylactic vaccine. Complications include cirrhosis, end-stage liver disease, and hepatocellular carcinoma, which collectively resulted in approximately 1.08 million deaths in 2022, according to the European Association for the Study of the Liver’s 2025 clinical practice guidelines. Chronic HBV infection is the primary cause of liver cancer worldwide, and the mortality associated with HBV-related liver cancer continues to increase.
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, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses.
For more information, please visit www.aligos.com 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 August 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.
Aligos Therapeutics
Contact
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@inzioevoke.com
FAQ
What is the primary endpoint of Aligos Therapeutics' (ALGS) Phase 2 B-SUPREME study?
How many patients will be enrolled in Aligos' (ALGS) Phase 2 B-SUPREME trial?
When will Aligos Therapeutics (ALGS) report results from the B-SUPREME study?
What is ALG-000184 being compared to in the Phase 2 trial?
How long will patients be treated in the Aligos (ALGS) Phase 2 B-SUPREME study?
