ALG-000184 for Hepatitis B

(B-SUPREME Trial)

Recruiting at 44 trial locations

Overseen By Aligos Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Aligos Therapeutics

Disqualifiers: Hepatitis A, C, D, E, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment, ALG-000184, against the existing medication Tenofovir Disoproxil Fumarate (TDF) for individuals with chronic Hepatitis B. Researchers aim to assess the effectiveness and safety of ALG-000184 over 48 weeks compared to TDF. The trial consists of two parts: one group starts with TDF and then switches to ALG-000184, while the other group takes ALG-000184 throughout. Individuals with chronic Hepatitis B who have not recently or ever received treatment and meet specific lab criteria may qualify. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Do I need to stop my current medications to join the trial?

The trial requires that you have not been on HBV antiviral medicines or investigational anti-HBV agents for at least 6 months or 5 half-lives before joining. If you are currently on such treatments, you would need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ALG-000184 was well tolerated in earlier studies. In a previous trial, healthy volunteers took ALG-000184 for about a month without major safety concerns or severe side effects, indicating its safety in humans.

Tenofovir Disoproxil Fumarate (TDF) is already FDA-approved for treating hepatitis B, confirming its safety for human use. While generally well tolerated, some individuals might experience mild side effects like nausea or dizziness.

In conclusion, both ALG-000184 and TDF have been well tolerated in past research. However, ALG-000184 is still undergoing testing for safety and effectiveness in ongoing trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Hepatitis B?

Unlike the standard of care for Hepatitis B, which typically includes medications like Tenofovir Disoproxil Fumarate (TDF) that work by inhibiting the virus's ability to replicate, ALG-000184 offers a new approach. Researchers are excited about ALG-000184 because it is designed to specifically target and interfere with the virus's life cycle in a potentially more effective way. This novel mechanism could enhance treatment outcomes and possibly lead to a functional cure, which would be a significant advancement over current treatments that primarily focus on viral suppression.

What evidence suggests that this trial's treatments could be effective for chronic HBV infection?

Research has shown that ALG-000184, one of the treatments in this trial, may help treat chronic Hepatitis B. In one study, 60% of patients taking ALG-000184 had very low levels of the virus in their blood after 48 weeks. When the treatment continued, all patients reached this low level. The treatment works by greatly reducing the virus's genetic material in the body. This suggests ALG-000184 could be a strong new option for managing Hepatitis B. Participants in this trial will receive either ALG-000184 or Tenofovir Disoproxil Fumarate (TDF) for 48 weeks, followed by open-label treatment with ALG-000184 for another 48 weeks. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with chronic Hepatitis B who have never been treated with HBV antiviral medicines or haven't had such treatments in the last 6 months. Participants must be HBeAg-positive without anti-HBe antibodies, or HBeAg-negative, have high levels of HBsAg and HBV DNA, and ALT values up to 8 times the upper limit.

Inclusion Criteria

My HBV DNA level is 20,000 IU/mL or higher.

1. Have never received treatment with HBV antiviral medicines (NA, interferon) or investigational anti-HBV agents including a CAM \[i.e., Treatment Naïve (TN) subjects\], OR 2. Have not been on treatment with approved (NA, interferon) or investigational HBV antiviral medicines (e.g., antisense oligonucleotides or small interfering RNAs) within 6 months or 5 half-lives (whichever is longer) prior to randomization (i.e., Currently Not Treated (CNT) subjects).

I am either HBeAg-positive without HBeAb or HBeAg-negative.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 48 weeks of oral once daily monotherapy with ALG-000184 or Tenofovir Disoproxil Fumarate

48 weeks

Open-label extension

Participants receive an additional 48 weeks of open-label treatment with ALG-000184

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ALG-000184
• Tenofovir Disoproxil Fumarate

Trial Overview The study compares a new oral medication called ALG-000184 against an existing drug, Tenofovir Disoproxil Fumarate (TDF), over a period of 48 weeks. The goal is to assess which treatment is more effective and safer for individuals with chronic hepatitis B infection.

How Is the Trial Designed?

Group I: ALG-000184 Experimental Treatment 1 Intervention

Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks.

Group II: TDF Active Control 1 Intervention

Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks.

Who Is Running the Clinical Trial?

Aligos Therapeutics

Lead Sponsor

Trials

11

Recruited

960+

Founded

2018

Headquarters

South San Francisco, United States

Known For

Liver & Viral Therapies

Top Products

ALG-000184, ALG-055009, ALG-097558

Citations

1. investor.aligos.com investor.aligos.com/news-releases/news-release-details/aligos-therapeutics-announces-first-subject-dosed-phase-2-b

Release Details 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06963710

NCT06963710 | A Study Evaluating the Efficacy and Safety ... 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 ...

3. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/supreme-trial-launches-alg-000184-chronic-hepatitis-b

Phase II B-SUPREME Trial Launches for ALG-000184 in ... The study compares ALG-000184 monotherapy to tenofovir disoproxil fumarate over 48 weeks, with primary endpoints focused on HBV DNA suppression ...

4. biospace.com biospace.com/press-releases/aligos-therapeutics-presents-positive-data-at-the-liver-meeting-2025

Aligos Therapeutics Presents Positive Data at The Liver ... At Week 48, 6 of 10 subjects (60%) achieved HBV DNA < LLOQ (10 IU/mL, TD or TND). With treatment extension, this rate increased to 10 of 10 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39575679/

The Discovery and Preclinical Profile of ALG-000184, a ... ALG-000184 is currently being explored in multiple clinical trials in HBV-infected subjects where unprecedented reductions in HBV DNA, RNA and other viral ...

6. aligos.com aligos.com/wp-content/uploads/2021/02/Safety-Tolerability-and-Pharmacokinetics-of-Single-Ascending-Doses-of-ALG-000184-a-Class-II-Capsid-Assembly-Modulator-for-the-Treatment-of-Chronic-Hepatitis-B-CHB-in-Healthy-Volunteers-HV.pdf

Safety, Tolerability and Pharmacokinetics of Single ... There were no clinically meaningful differences in the safety or PK profile of ALG-000184/ALG-001075 between Asian and non-Asian healthy volunteers. • These ...

7. liverdiseasenews.com liverdiseasenews.com/news/dosing-begins-phase-2-trial-alg-000184-hepatitis-b/

Dosing begins in Phase 2 trial of ALG-000184 for hepatitis B Data from a Phase 1 clinical trial (NCT04536337) showed that about a month of ALG-000184 treatment was well tolerated in healthy volunteers and ...

8. natap.org natap.org/2023/HBV/GHSALIGOSDeckFINALDRAFTv.pdf

GHS ALIGOS Deck - FINAL DRAFT v3 define safety, PK and antiviral activity of ALG-000184 + ETV. • ALG-000184 appears to have best in class properties and could contribute to enhanced rates of ...