Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABI-H0731 · 4 trials · 1 indication
Hepatitis B virus (HBV) DNA was measured using COBAS TaqMan Version 2.0. The lower limit of quantitation (LLOQ) was 20 IU/mL and the limit of detection (LOD) was 10 IU/mL.
| Arm | Type | Description |
|---|---|---|
| ABI-H0731 + SOC ETV | EXPERIMENTAL | Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. |
| Placebo + SOC ETV | EXPERIMENTAL | Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. |
| ABI-H0731 + SOC NUC | EXPERIMENTAL | Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary. |
| Placebo + SOC NUC | ACTIVE_COMPARATOR | Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary. |
| Cohort B1 | EXPERIMENTAL | ABI-H0731 or Placebo in varying doses by mouth for 28 days |
| Cohort B2 | EXPERIMENTAL | ABI-H0731 or Placebo in varying doses by mouth for 28 days |
| Cohort B3 | EXPERIMENTAL | ABI-H0731 or Placebo in varying doses by mouth for 28 days |
| Cohort B4 | EXPERIMENTAL | ABI-H0731 or Placebo in varying doses by mouth for 28 days |
| Cohort B5 | EXPERIMENTAL | ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days |
| Cohort B6 | EXPERIMENTAL | ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days |
| ABI-H0731 or Matching Placebo | EXPERIMENTAL | ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days |
| ABI-H0731 or Placebo and ETV or TDF | EXPERIMENTAL | ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days |
| ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys | EXPERIMENTAL | ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days |
| Name | Type | Description |
|---|---|---|
| ABI-H0731 | DRUG | Participants will receive 300mg QD of ABI-H0731 tablets orally. |
| SOC ETV | DRUG | Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert. |
| Placebo Oral Tablet | DRUG | Participants will receive matching QD placebo tablets orally. |
| SOC NUC | DRUG | Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert. |
| Placebo for ABI-H0731 | DRUG | Sugar pill manufactured to mimic the ABI-H0731 tablet |
| Entecavir | DRUG | An antiviral medication used in the treatment of hepatitis B virus infection |
| Tenofovir Disoproxil Fumarate | DRUG | An antiviral medication used in the treatment of hepatitis B virus infection |
| Pegasys | DRUG | Used to treat adults with chronic hepatitis B virus who show signs of liver damage |
| Nucleos(t)ide | DRUG | Used to treat adults with chronic hepatitis B virus |
Key Inclusion Criteria: * Male or female between ages 18 and 70 years * HBeAg-positive at screening * In good general health except for cHBV * HBV viral load ≥2×105 IU/mL * Hepatitis B surface antigen (HBsAg) \>1000 IU/mL at screening Key Exclusion Criteria: * Any prior treatment with lamivudine ...
ABI-H0731 is an investigational small molecule developed for the treatment of chronic hepatitis B virus infection. It has been studied both as an adjunctive therapy alongside existing antivirals and in combination with entecavir in viremic HBeAg-positive patients with chronic hepatitis B.
ABI-H0731 targets the hepatitis B virus core protein, a viral protein involved in capsid assembly and viral replication. By binding the HBV core protein, the drug is designed to interfere with the viral life cycle. It is a small molecule developed by Assembly Biosciences.
ABI-H0731 is being developed by Assembly Biosciences, Inc., a biopharmaceutical company that trades under the ticker ASMB. Assembly Biosciences has sponsored the clinical program evaluating ABI-H0731 in chronic hepatitis B, including Phase 1 and Phase 2 studies conducted across multiple countries.
ABI-H0731 has reached Phase 2 clinical development for chronic hepatitis B. It is investigational and has not been approved by the FDA. Four clinical trials of ABI-H0731 have been completed, including two Phase 2 studies and two Phase 1 studies, with no trials currently active.
ABI-H0731 has been evaluated in four completed trials: NCT03577171, which tested ABI-H0731 plus entecavir versus entecavir alone in viremic HBeAg-positive chronic hepatitis B patients; NCT03576066, which studied it as adjunctive therapy; and the Phase 1 studies NCT03109730 and NCT02908191.
Across the four completed clinical trials, 222 participants were enrolled. The Phase 2 study NCT03577171 enrolled 25 participants, the Phase 2 adjunctive therapy study NCT03576066 enrolled 73, the Phase 1b/2a study NCT03109730 enrolled 38, and the Phase 1 study NCT02908191 enrolled 86.