Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABI-H2158 · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1: ABI-H2158 + Itraconazole | EXPERIMENTAL | Oral ABI-H2158 on Days 1 and 9; oral itraconazole once-daily (QD) on Days 6 through 13 |
| Cohort 2: ABI-H2158 + Rifampin | EXPERIMENTAL | Oral ABI-H2158 on Days 1 and 12; oral rifampin QD on Days 6 through 16 |
| Cohort 3: ABI-H2158 + Esomeprazole | EXPERIMENTAL | Oral ABI-H2158 on Days 1 and 11; oral esomeprazole QD on Days 6 through 11 |
| Cohort 4: ABI-H2158 + Midazolam | EXPERIMENTAL | Oral midazolam on Days 1 and 11; oral ABI-H2158 QD on Days 2 through 11 |
| Cohort 5: ABI-H2158 + Oral Contraceptive | EXPERIMENTAL | Cycle 1: active oral contraceptive (ethinyl estradiol/levonorgestrel) QD on Days 1 through 21 and oral placebo QD on Days 22 through 28; Cycle 2: active oral contraceptive QD on Days 1 through 21, oral placebo QD on Days 22 through 26, and oral ABI-H2158 QD on Days 11 through 24 |
| Group 1 | EXPERIMENTAL | ABI-H2158 Reference Formulation in a fasting state on Day 1 (Period 1), then ABI-H2158 Test Formulation in a fasting state on Day 8 (Period 2), then ABI-H2158 Test Formulation after a high-fat meal on Day 15 (Period 3) |
| Group 2 | EXPERIMENTAL | ABI-H2158 Test Formulation in a fasting state on Day 1 (Period 1), then ABI-H2158 Test Formulation after a high-fat meal on Day 8 (Period 2), then ABI-H2158 Reference Formulation in a fasting state on Day 15 (Period 3) |
| Group 3 | EXPERIMENTAL | ABI-H2158 Test Formulation after a high-fat meal on Day 1 (Period 1), then ABI-H2158 Reference Formulation in a fasting state on Day 8 (Period 2), then ABI-H2158 Test Formulation in a fasting state on Day 15 (Period 3) |
| ABI-H2158 | EXPERIMENTAL | ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days |
| Matching Placebo for ABI-H2158 | PLACEBO_COMPARATOR | Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days |
| Name | Type | Description |
|---|---|---|
| ABI-H2158 | DRUG | ABI-H2158 tablets |
| Itraconazole | DRUG | Itraconazole capsules |
| Rifampin | DRUG | Rifampin capsules |
| Midazolam | DRUG | Midazolam syrup |
| Ethinyl Estradiol / Levonorgestrel | DRUG | Ethinyl Estradiol / Levonorgestrel tablets |
| Esomeprazole | DRUG | Esomeprazole capsules |
| Placebo matching oral contraceptive | DRUG | Placebo matching Ethinyl Estradiol / Levonorgestrel tablets |
| ABI-H2158 Reference Formulation | DRUG | ABI-H2158 tablets Reference Formulation |
| ABI-H2158 Test Formulation | DRUG | ABI-H2158 tablets Test Formulation |
| Placebo for ABI-H2158 | DRUG | Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets |
Inclusion Criteria: 1. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening. 2. Cohort 5: naive to the use of oral contraceptives. Exclusion Criteria: 1\. Positive test results for human immunodeficiency virus (HIV) or hepatiti...
ABI-H2158 is an investigational small molecule being developed for the treatment of chronic hepatitis B. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers and patients with chronic hepatitis B to evaluate its safety, tolerability, and pharmacokinetics.
ABI-H2158 is being developed by Assembly Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ASMB. The company is conducting clinical trials of ABI-H2158 in multiple countries, including the United States, Australia, China, Hong Kong, New Zealand, South Korea, and the United Kingdom.
ABI-H2158 is in Phase 1 clinical development. All three clinical trials for ABI-H2158 have been completed, with a total enrollment of 175 participants. The drug remains investigational and has not received FDA approval. It is being studied for the treatment of chronic hepatitis B.
ABI-H2158 has been studied in three completed Phase 1 clinical trials. NCT03714152 evaluated the drug in healthy volunteers and patients with chronic hepatitis B across multiple countries. NCT04083716 assessed relative bioavailability and food effects in healthy adults. NCT04142762 examined drug interactions with CYP3A4 modulators, oral contraceptives, and pH modifiers.
No, ABI-H2158 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for chronic hepatitis B. All completed trials have been early-stage studies focused on safety, tolerability, and pharmacokinetics in healthy volunteers and patients. The drug has not yet progressed to later-stage efficacy trials.