Approval Probability
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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 drug being developed for the treatment of chronic hepatitis B virus infection. It has been studied in adults with chronic hepatitis B, including both HBeAg-positive participants with viremia and patients receiving it as adjunctive therapy alongside existing antiviral treatment.
ABI-H0731 is being developed by Assembly Biosciences, Inc., which trades under the ticker ASMB. The company has sponsored the clinical trial program for the drug 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. Its trial program includes a Phase 1 study, a Phase 1b/2a study, and two Phase 2 studies, all of which are listed as completed. The drug remains investigational and is not described as approved.
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; NCT03109730, a Phase 1b/2a study; and NCT02908191, a Phase 1 study in healthy volunteers and patients.
Across its four completed clinical trials, ABI-H0731 has enrolled a total of 222 participants. Enrollment ranged from 25 participants in the entecavir combination study (NCT03577171) to 86 participants in the Phase 1 study (NCT02908191), with the trials including randomized, double-blind, controlled designs.
The ABI-H0731 clinical trials were run across multiple countries, including the United States, Canada, New Zealand, the United Kingdom, Hong Kong, Australia, South Korea, and Taiwan. Participants were adults aged 18 years and older, and the studies enrolled both patients with chronic hepatitis B and healthy volunteers.