Vir Biotechnology’s Phase 2 Data for Hepatitis D Combo Regimen Highlights Market Potential
Vir Biotechnology's Phase 2 SOLSTICE trial evaluated the combination of tobevibart and elebsiran in adults with chronic hepatitis D45.
Interim data showed that the combo regimen rapidly and significantly suppressed hepatitis delta virus (HDV) levels, normalizing liver damage markers after about six months, with benefits extending for over a year41014.
High response rates were observed:
66% (21/32) of patients receiving monthly tobevibart and elebsiran had undetectable HDV RNA after treatment, with favorable safety—no severe adverse events or treatment-related discontinuations512.
These promising Phase 2 results helped Vir secure new regulatory designations in the US and EU, underscoring the strong unmet medical need and suggesting substantial commercial opportunity if the therapy is approved410.
Vir is actively launching the ECLIPSE Phase 3 program, with two Phase 3 trials and one Phase 2 trial planned to begin soon; full enrollment for the global ECLIPSE 1 trial has already been achieved, aiming for data in early 202716.
The combo's efficacy and safety profile positions Vir's regimen as a potential market leader, possibly challenging Gilead and others in a space with currently no approved treatments for hepatitis D in the US2.
Sources:
1. https://liverdiseasenews.com/news/enrollment-complete-eclipse-1-trial-testing-hepatitis-d-treatment-combo/
2. https://www.fiercebiotech.com/biotech/vir-steers-hepatitis-d-combo-deeper-clinic-keeping-pressure-gilead-midphase-data
4. https://liverdiseasenews.com/news/hepatitis-d-treatment-combo-granted-new-designations-us-eu/
5. https://investors.vir.bio/news/news-details/2025/Vir-Biotechnology-Announces-AASLD-The-Liver-Meeting-Presentation--New-England-Journal-of-Medicine-Publication-of-Phase-2-Data-Demonstrating-Tobevibart--Elebsiran-Combination-Deliver-High-Rates-of-Undetectable-HDV-RNA-with-Favorable-Safety-Profile/default.aspx
6. https://investors.vir.bio/news/news-details/2025/Vir-Biotechnology-Initiates-Second-Pivotal-Trial-in-Its-Global-ECLIPSE-Registrational-Program-for-Chronic-Hepatitis-Delta/default.aspx
10. https://trial.medpath.com/news/29330e0ca1d11fee/phase-3-trials-of-treatment-combo-for-hepatitis-d-expected-in-2025-liver-disease-news
12. https://www.appliedclinicaltrialsonline.com/view/hepatitis-delta-treatment-fda-ind-clearance-fast-track-designation-phase-ii-results
14. https://investors.vir.bio/news/news-details/2024/Vir-Biotechnology-Presents-Positive-Chronic-Hepatitis-Delta-Clinical-Trial-Data-and-Announces-Initiation-of-Phase-3-Registrational-Program/default.aspx