Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALG-000184 · 2 trials · 2 indications
HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target detected or target not detected) at Week 48
HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target not detected) at Week 48
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
| Arm | Type | Description |
|---|---|---|
| ALG-000184 | EXPERIMENTAL | Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks. |
| TDF | ACTIVE_COMPARATOR | Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks. |
| Placebo | PLACEBO_COMPARATOR | Oral tablet(s) of placebo in HV or CHB subjects once daily for up to 12 weeks |
| Entecavir in combination with ALG-000184 | ACTIVE_COMPARATOR | Oral tablet(s) of ALG-000184 in combination with Entecavir in CHB subjects once or twice daily for up to 96 weeks |
| Placebo plus Entecavir | ACTIVE_COMPARATOR | Oral tablet(s) of matching placebo in combination with Entecavir in CHB subjects once daily for 12 weeks, with option to switch to open-label ALG-000184 plus Entecavir for up to 96 weeks (Part 4). |
| Open-label ALG-000184 plus Entecavir | EXPERIMENTAL | Open-label oral tablet(s) of ALG-000184 in combination with Entecavir in CHB subjects once daily for up to 96 weeks (Part 5) |
| Name | Type | Description |
|---|---|---|
| ALG-000184 | DRUG | 300 mg tablet |
| TDF | DRUG | 300 mg tablet |
| Placebo | DRUG | Single or multiple doses of Placebo |
| Entecavir | DRUG | multiple doses of Entecavir |
Key Inclusion Criteria: 1. Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2 (or minimun age by local regulatory requirements). 2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2). 3. HBsAg ≥LLOQ. 4. HBV DNA ≥20,000 IU...
ALG-000184 is an investigational small molecule antiviral being developed by Aligos Therapeutics for the treatment of chronic hepatitis B infection. It is designed to act against the hepatitis B virus and is given orally. It remains in clinical development and has not been approved for commercial use.
ALG-000184 is being studied for the treatment of chronic hepatitis B infection, including both HBeAg-positive and HBeAg-negative adult patients. Clinical testing has enrolled adults aged 18 years and older, including healthy volunteers in early studies and untreated patients with chronic hepatitis B in later-stage evaluation.
ALG-000184 targets the hepatitis B virus (HBV). It is a small molecule antiviral directed at the virus itself rather than at a human host protein. Targeting HBV directly is intended to interfere with the viral lifecycle that sustains chronic infection, and the compound is being evaluated for its antiviral activity in patients.
ALG-000184 is being developed by Aligos Therapeutics, Inc., a clinical-stage biopharmaceutical company that trades under the ticker symbol ALGS. Aligos is the sponsor of the clinical program evaluating the compound in chronic hepatitis B, including the Phase 2 B-SUPREME study.
ALG-000184 is in clinical development. A Phase 1 study in healthy volunteers and chronic hepatitis B subjects has been completed, and the compound is now being evaluated in a Phase 2 trial. It is investigational and has not been approved by the FDA or any other regulatory authority.
ALG-000184 has been studied in two registered trials. NCT04536337 was a completed Phase 1 study of safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers and chronic hepatitis B subjects. NCT06963710, known as B-SUPREME, is an active Phase 2 study comparing ALG-000184 with tenofovir disoproxil fumarate in untreated HBeAg-positive and HBeAg-negative adults with chronic hepatitis B.