Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABI-4334 Tablet
ABI-4334 · 2 trials · 1 indication
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
| Arm | Type | Description |
|---|---|---|
| ABI-4334 | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Part A: SAD Cohorts 1-5 ABI-4334 Tablet | EXPERIMENTAL | A single dose of ABI-4334 will be administered on Day 1 in dose-escalation cohorts with a starting dose of 30 mg. The doses for subsequent cohorts will be determined by evaluation of safety and PK data from previous cohorts. |
| Part A: SAD Cohorts 1-5 ABI-4334 Placebo Tablet | PLACEBO_COMPARATOR | A single dose of placebo matching ABI-4334 will be administered on Day 1. |
| Part A: SAD Fed Cohorts 6-7 ABI-4334 Tablet | EXPERIMENTAL | A single dose of ABI-4334 will be administered after a high-fat meal on Day 1 in cohort 6. A single dose of ABI-4334 will be administered on two separate occasions, once fasted and once after a high-fat meal in cohort 7. The dose administered will be determined after evaluation of cumulative safety and PK data from cohorts 1-5. |
| Part A: SAD Fed Cohorts 6 ABI-4334 Placebo Tablet | PLACEBO_COMPARATOR | A single dose of placebo matching ABI-4334 will be administered on Day 1 after a high-fat meal on Day 1 in cohort 6. |
| Part B: MAD Cohorts 1-2 ABI-4334 Tablet | EXPERIMENTAL | Once-daily doses of ABI-4334 will be administered from Day 1 to Day 8. Cohort B1 will receive a dose determined from evaluation of the data from the SAD cohorts. The doses for the subsequent cohort will be determined by evaluation of safety and PK data from previous cohorts. |
| Part B: MAD Cohorts 1-2 ABI-4334 Placebo Tablet | PLACEBO_COMPARATOR | Once-daily doses of placebo matching ABI-4334 will be administered from Day 1 to Day 8. |
| Name | Type | Description |
|---|---|---|
| ABI-4334 | DRUG | 10 mg or 50 mg tablets for oral administration |
| Placebo | DRUG | 10 mg or 50 mg tablets for oral administration |
| ABI-4334 Tablet | DRUG | ABI-4334 Tablet |
| ABI-4334 Placebo | DRUG | Placebo to ABI-4334 Tablet |
Inclusion Criteria: 1. Body mass index (BMI) ≥ 18.0 and \< 35.0 kg/m(2), where BMI = weight (kg)/(height \[m\])(2) with a minimum body weight of 45 kg 2. Chronic hepatitis B infection, defined as HBV infection for ≥ 6 months documented 3. Treatment-naïve or off-antiviral therapy for ≥ 24 weeks prio...
ABI-4334 is an investigational small molecule being developed for the treatment of chronic hepatitis B virus infection. It is not yet approved for any indication and remains in clinical development. The clinical program has evaluated the drug in adults with chronic hepatitis B as well as in healthy volunteers.
ABI-4334 is being developed by Assembly Biosciences, Inc., which trades on the Nasdaq under the ticker ASMB. The company is the sponsor of the clinical program evaluating the drug in chronic hepatitis B.
ABI-4334 is in Phase 1 clinical development. Two Phase 1 trials have been completed: a first-in-human study in healthy subjects and a study assessing safety, pharmacokinetics, and antiviral activity in subjects with chronic hepatitis B virus infection. The drug is investigational and has not been approved by the FDA.
ABI-4334 has been studied in two completed Phase 1 trials. NCT05569941 was a first-in-human study of safety, tolerability, and pharmacokinetics in 54 healthy subjects in New Zealand. NCT06384131 assessed safety, pharmacokinetics, and antiviral activity in 20 subjects with chronic hepatitis B in Moldova and New Zealand.
Yes. ABI-4334 Tablet is an alternative name for ABI-4334, the investigational small molecule developed by Assembly Biosciences for chronic hepatitis B. Searches for either name refer to the same clinical-stage drug candidate.
Both completed Phase 1 trials of ABI-4334 were randomized, double-blind, and placebo-controlled. Together they enrolled 74 participants. One trial included 54 healthy volunteers in New Zealand, and the other enrolled 20 adults with chronic hepatitis B in Moldova and New Zealand.