Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALG-000184 · 3 trials · 3 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
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1)
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2)
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1)
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1)
Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1)
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. |
| Carbamazepine | EXPERIMENTAL | Multiple doses of carbamazepine, a strong CYP3A4 inducer, to evaluate potential drug-drug interactions with ALG-000184 |
| Itraconazole | EXPERIMENTAL | Multiple doses of itraconazole, a strong CYP3A4 inhibitor, to evaluate potential drug-drug interactions with ALG-000184. |
| 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 |
| Carbamazepine | DRUG | Commercially available supply. |
| Itraconazole (Sporanox) | DRUG | Commercially available supply. |
| 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 being developed for chronic hepatitis B infection. It is being studied in healthy volunteers and in patients with chronic hepatitis B, including HBeAg-positive and HBeAg-negative adult subjects. The drug is currently in clinical development and has not been approved by regulatory authorities.
ALG-000184 targets the hepatitis B virus (HBV). It is a small molecule designed to act against the virus that causes chronic hepatitis B infection. The drug is being evaluated for its safety, tolerability, pharmacokinetics, and pharmacodynamics in clinical trials.
ALG-000184 is being developed by Aligos Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALGS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating chronic hepatitis B infection.
ALG-000184 is in Phase 1 and Phase 2 clinical development. One Phase 1 trial has been completed, another Phase 1 trial is active but not recruiting, and a Phase 2 trial is currently recruiting participants. The drug is investigational and has not been approved by the FDA.
ALG-000184 is being studied in three clinical trials. NCT04536337 is a completed Phase 1 study in healthy volunteers and chronic hepatitis B subjects. NCT06672900 is an active Phase 1 study in healthy volunteers. NCT06963710 is a recruiting Phase 2 study comparing ALG-000184 with tenofovir disoproxil fumarate in chronic hepatitis B patients.
No, ALG-000184 is not the same as tenofovir disoproxil fumarate. Tenofovir disoproxil fumarate is a comparator drug used in a Phase 2 clinical trial to evaluate the efficacy and safety of ALG-000184 in untreated adult subjects with chronic hepatitis B infection.