Drugs / Vebicorvir
Vebicorvir
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04637139 | Dec 2020 | chronic hepatitis B virus infection | Assembly Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT02908191 | Nov 2016 → Mar 2018 | chronic hepatitis B virus infection | Assembly Biosciences | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03109730 | Jun 2017 → Mar 2018 | chronic hepatitis B virus infection | Assembly Biosciences | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT05238844 | Apr → May 2022 | chronic hepatitis B virus infection | Antios Therapeutics, Inc | Terminated | No outcome recorded |
| Phase 2 | NCT04781647 | Feb 2021 → Dec 2022 | chronic hepatitis B virus infection | Assembly Biosciences | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04454567 | Nov 2020 → Apr 2021 | chronic hepatitis B virus infection | Assembly Biosciences | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03577171 | Jun 2018 → Jun 2019 | chronic hepatitis B virus infection | Assembly Biosciences | Completed | Met primary |
| Phase 2 | NCT03576066 | Jun 2018 → Jul 2019 | chronic hepatitis B virus infection | Assembly Biosciences | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2023-11-10 | Assembly Biosciences | Results Assembly Biosciences Presents New Data Highlighting Viral Hepatitis Portfolio at AASLD The Liver Meeting® assemblybio.com ↗
Additionally, the Phase 2 data reported for vebicorvir in combination with Nrtl and Arbutus Biopharma’s AB-729 provide further insights that may inform future studies for the HBV and liver disease scientific community. |
| 2023-06-21 | Assembly Biosciences | Results Assembly Biosciences Presents New Data Highlighting Entry Inhibitor and Core Inhibitor Programs at EASL’s International Liver Congress™ 2023 assemblybio.com ↗
The first-generation core inhibitor candidate, VBR, was evaluated in a Phase 2 study in combination with entecavir (ETV) and pegylated interferon alpha (Peg-IFNα) in patients with hepatitis B e antigen positive cHBV infection. |
| 2022-11-04 | Assembly Biosciences | Results Assembly Biosciences Presents New Data at AASLD The Liver Meeting® Highlighting Breadth of Virology Portfolio and Potential of Next-Generation Core Inhibitors in HBV assemblybio.com ↗
Clinical results from the study evaluating first-generation core inhibitor vebicorvir (VBR) in combination with Arbutus Biopharma’s AB-729 in HBV are presented in the late-breaking poster entitled “Evaluation of the vebicorvir, NrtI, and AB-729 combination in virologically suppressed patients with HBeAg negative chronic hepatitis B virus infection: Interim analysis from an open label phase 2 study.” |
| 2022-07-20 | Assembly Biosciences | Results Assembly Biosciences Announces Program Reprioritization and Organizational Update assemblybio.com ↗
The data indicate that the triple combinations do not show a benefit in multiple key viral parameters compared to the dual combinations without VBR in either study. |
| 2022-06-22 | Assembly Biosciences | Results Assembly Biosciences Presents New Data Highlighting Clinical Progress of Core Inhibitor Programs at EASL’s International Liver Congress™ 2022 assemblybio.com ↗ |
| 2022-06-08 | Assembly Biosciences | Results Assembly Biosciences to Highlight Data from HBV Core Inhibitor Programs at EASL’s International Liver Congress™ 2022 assemblybio.com ↗
Greater sequence diversity during early hepatitis B virus decline on vebicorvir plus entecavir is associated with a lower level of virus rebound following switch to entecavir monotherapy |
| 2021-11-12 | Assembly Biosciences | Results Assembly Biosciences Presents New Data at AASLD The Liver Meeting™ Highlighting the Progress of its HBV Core Inhibitor Portfolio assemblybio.com ↗
Vebicorvir Phase 2 open-label study data demonstrate the contribution of core inhibition to deepen viral suppression |
| 2021-11-01 | Assembly Biosciences | Results Assembly Biosciences Abstracts Selected for Presentation at the Upcoming AASLD The Liver Meeting® assemblybio.com ↗
HBV pgRNA and DNA both rebound immediately following discontinuation of the core inhibitor vebicorvir despite continued NrtI treatment in patients with HBeAg positive chronic hepatitis B |
| 2021-06-23 | Assembly Biosciences | Results Assembly Biosciences Presents Data from HBV Core Inhibitor Programs at the International Liver Congress™ EASL 2021 assemblybio.com ↗
Post hoc analyses suggest HBcrAg level may be an important component when establishing stopping criteria for future trials. |
| 2020-11-13 | Assembly Biosciences | Results Assembly Biosciences Presents Data from HBV Core Inhibitor Programs in Poster Sessions at the 2020 AASLD The Liver Meeting Digital Experience™ assemblybio.com ↗
These longer-term safety data, along with the demonstrated association of HBV pgRNA and changes in HBV viral antigens presented at this conference, are very encouraging and support the continued advancement of the company’s core inhibitor programs. |
| 2020-11-05 | Assembly Biosciences | Results Assembly Biosciences Provides Update on the Ongoing Phase 2 Extension Study of Vebicorvir in Patients with Chronic Hepatitis B Virus Infection assemblybio.com ↗
The study has not achieved meaningful SVR rates as 39 of 41 patients have now relapsed. |
| 2020-08-28 | Assembly Biosciences | Results Clinical Data from Assembly Biosciences’ HBV Core Inhibitors Presented at The Digital International Liver CongressTM EASL 2020 assemblybio.com ↗ |
| 2019-11-11 | Assembly Biosciences | Results Data for Assembly Biosciences’ First and Second Generation HBV Core Inhibitors in Development for the Treatment of Chronic Hepatitis B Highlighted in Late-Breaker Poster Session at AASLD 2019 assemblybio.com ↗
Final Week 24 results from HBeAg-positive patients in Study 202 (n=25) demonstrated faster and deeper HBV DNA declines in patients receiving 731+entecavir (ETV) than those receiving ETV alone. |
| 2019-10-16 | Assembly Biosciences | Results Safety and Antiviral Activity of Assembly Biosciences’ First and Second Generation Core Inhibitor Candidates In the Treatment of Chronic Hepatitis B to be Featured in a Late Breaking Session at AASLD assemblybio.com ↗
Phase 2a studies of ABI-H0731 + nucleos(t)ide analogs (Nrtl) in HBeAg+ patients show faster and deeper declines in HBV DNA and RNA with combination than Nrtl alone, as well as subsequent declines in the surrogate markers of cccDNA with long-term treatment |
| 2019-04-13 | Assembly Biosciences | Results Assembly Biosciences Presents Interim Data from Two Phase 2a Studies of ABI-H0731 in HBV-Infected Subjects in a Late-Breaker Oral Session at EASL 2019 assemblybio.com ↗
The combination of 731 + entecavir (ETV) reduced both HBV DNA and HBV RNA significantly faster and deeper compared to ETV monotherapy as early as week 2. |
| 2018-11-12 | Assembly Biosciences | Results Assembly Biosciences Presents Final Results of Phase 1b Study of ABI-H0731 at 2018 AASLD assemblybio.com ↗
All cohorts yielded potent antiviral activity, with mean maximal HBV DNA declines of 2.8 |
| 2018-10-02 | Assembly Biosciences | Results Assembly Biosciences Announces Oral Presentation at 2018 AASLD assemblybio.com ↗
ABI-H0731 was safe and well tolerated, with dose dependent antiviral effects at doses ranging from 100 to 400 mg given orally once daily, and RNA declines paralleled the observed DNA declines. |
| 2018-07-25 | Assembly Biosciences | Regulatory Assembly Biosciences Announces FDA Fast Track Designation Granted to ABI-H0731 for the Treatment of Hepatitis B Virus Infection assemblybio.com ↗ |
| 2018-04-12 | Assembly Biosciences | Results Assembly Biosciences Presents Positive Interim Data from Phase 1a and 1b Studies of ABI-H0731 in HBV Patients in a Late-Breaker Session at the EASL Conference assemblybio.com ↗ |
| 2018-03-28 | Assembly Biosciences | Results Assembly Biosciences Announces ABI-H0731 Phase 1b Interim Data Accepted as a Late-Breaker Poster at The International Liver Congress™ (EASL) assemblybio.com ↗
We believe we have identified the dose level sufficient to suppress cccDNA establishment and move forward into Phase 2a proof of concept studies this summer. |
| 2017-10-02 | Assembly Biosciences | Results Assembly Biosciences Announces 2017 AASLD Presentations assemblybio.com ↗
In a Phase 1a study, ABI-H0731 was well tolerated, with no serious adverse events. |
| 2017-02-16 | Assembly Biosciences | Results Assembly Biosciences Announces Successful Completion of ABI-H0731 Phase 1a Trial and Upcoming Conference Presentations assemblybio.com ↗
Favorable results from this segment of the study allow Assembly to advance ABI-H0731 into a Phase 1b study, which will assess its safety, pharmacokinetics and preliminary antiviral efficacy in patients with chronic HBV infection. |
| 2016-11-11 | Assembly Biosciences | Results Assembly Biosciences to Present Data on ABI-H0731 at AASLD 2016 Liver Meeting assemblybio.com ↗
Assembly has developed a proprietary series of CpAM compounds that can both suppress viral replication and inhibit the formation of cccDNA in HBV cell infection assays. |
All press releases naming this drug 29 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vebicorvir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05238844 ↗ |
| Known as | ABI-H0731 | “Vebicorvir (formerly ABI-H0731) is an orally administered, potent and selective small molecule inhibitor of the HBV core protein” NCT05238844 ↗ |
| Known as | VBR | “Vebicorvir (VBR)” NCT04637139 ↗ |
| Action | Inhibit | “an investigational inhibitor of the HBV core protein” PMID 31711752 ↗ Nov 2019 |
| Modality | Small molecule | “small molecule inhibitor” NCT05238844 ↗ |
| Route | Oral | “single oral doses of ABI-H0731 (100, 300, 600, or 1000 mg)” PMID 31711752 ↗ Nov 2019 |