Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied for its safety, tolerability, pharmacokinetics, and antiviral activity in patients with chronic Hepatitis B virus infection.
ABI-4334 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 to evaluate the drug's safety and efficacy in treating chronic Hepatitis B.
ABI-4334 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in healthy subjects and one in patients with chronic Hepatitis B. The drug is investigational and has not received FDA approval. It is still in the early stages of clinical testing.
ABI-4334 has completed two Phase 1 clinical trials. NCT05569941 assessed safety, tolerability, and pharmacokinetics in 54 healthy subjects in New Zealand. NCT06384131 evaluated safety, pharmacokinetics, and antiviral activity in 20 patients with chronic Hepatitis B in Moldova and New Zealand. Both trials are completed.
The mechanism of action for ABI-4334 has not been disclosed in the available information. It is a small molecule being studied for the treatment of chronic Hepatitis B, but its specific molecular target has not been publicly detailed.