Approval Probability
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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 being developed for the treatment of chronic hepatitis B. It has been studied in clinical trials as a potential therapy for this viral infection, including as an adjunctive treatment in combination with other antiviral agents.
ABI-H0731 is being developed by Assembly Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ASMB. The company has conducted multiple clinical trials evaluating this investigational drug for chronic hepatitis B.
ABI-H0731 has completed Phase 2 clinical trials for chronic hepatitis B. All four clinical studies listed for the drug are completed, including two Phase 2 trials. The drug remains investigational and has not been approved by regulatory authorities.
ABI-H0731 has been studied in four completed clinical trials: NCT02908191, a Phase 1 study in healthy volunteers and patients; NCT03109730, a Phase 1b/2a study; NCT03576066, a Phase 2 adjunctive therapy study; and NCT03577171, a Phase 2 study comparing ABI-H0731 plus entecavir versus entecavir alone.
ABI-H0731 is a small molecule antiviral agent being studied for chronic hepatitis B. Its mechanism of action has not been specified in the available clinical trial information, but it is being evaluated as a potential treatment for this viral infection.