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Also known as Vebicorvir (VBR), ABI-H0731
Vebicorvir · 5 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. |
| Group 1 | EXPERIMENTAL | VBR 300 mg solution containing 2 µCi \[14C\]VBR |
| 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. |
| Vebicorvir (VBR) | DRUG | 300mg Vebicovir containing 2 µCi \[14C\]VBR. |
| 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 ...
Vebicorvir is an investigational small molecule being developed for the treatment of chronic hepatitis B, a long-term viral infection of the liver. It is in Phase 1 clinical development and is not approved for any indication. Assembly Biosciences, Inc. is the developer.
Vebicorvir 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 for this chronic hepatitis B candidate.
Vebicorvir is in Phase 1 clinical development. It is an investigational small molecule for chronic hepatitis B and has not been approved by the FDA. The program has completed one Phase 1 trial to date, with no active trials currently listed.
Vebicorvir has been studied in one completed Phase 1 trial, NCT04637139, titled A Study to Evaluate the Mass Balance Absorption and AME of VBR. That trial enrolled 6 healthy male volunteers aged 18 years and older in the United States and was an uncontrolled study.
Yes. Vebicorvir is also referred to as VBR, an abbreviation used in its clinical trial documentation. Both names refer to the same investigational small molecule being developed by Assembly Biosciences for chronic hepatitis B.