Vir Biotechnology to Present 96-Week Data from Phase 2 SOLSTICE Trial for Chronic Hepatitis Delta at EASL Congress 2026
核心洞察
Vir Biotechnology will present complete Week 96 data from the Phase 2 SOLSTICE trial evaluating tobevibart and elebsiran combination therapy for chronic hepatitis delta at EASL Congress 2026.
The oral presentation has been selected for inclusion in "Best of EASL 2026" by the European Association for the Study of the Liver.
Chronic hepatitis delta is the most severe form of chronic viral hepatitis with no approved treatments in the U.S. and limited options globally.
Vir Biotechnology announced it will present comprehensive 96-week efficacy and safety data from its Phase 2 SOLSTICE clinical trial at the European Association for the Study of the Liver (EASL) Congress 2026 in Barcelona, Spain. The trial evaluates the combination of tobevibart and elebsiran for treating chronic hepatitis delta, a severe form of viral hepatitis with significant unmet medical need.
EASL Congress Presentations
The company's oral presentation, titled "Efficacy and safety of tobevibart (VIR-3434) alone or in combination with elebsiran (VIR-2218) in participants with chronic hepatitis delta virus infection: Week 96 endpoint results from the Phase 2 SOLSTICE trial," has been selected for inclusion in "Best of EASL 2026." The presentation will be delivered by Tarik Asselah on May 29, 2026, during General Session II.
Additionally, Vir will present a Week 48 subgroup analysis examining the impact of body mass index (BMI) on ALT normalization after successful viral control in patients treated with the combination therapy. This poster presentation, selected for the EASL poster tour, will be presented by Alina Jucov.
Addressing Critical Unmet Medical Need
Chronic hepatitis delta represents the most severe form of chronic viral hepatitis and was recently classified as carcinogenic by the International Agency for Research on Cancer. Patients with the disease rapidly progress to cirrhosis, liver failure, and liver-related death. Currently, no approved treatments exist in the United States, with limited therapeutic options available in the European Union and globally.
The disease's progression is driven by ongoing hepatitis delta virus (HDV) replication, making the achievement of undetectable virus levels a critical therapeutic goal. Patients with detectable HDV RNA (搜索) face significantly higher risks of liver-related events, including compensated and decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, and mortality compared to those with undetectable HDV RNA levels.
Novel Combination Therapy Approach
The investigational combination of tobevibart and elebsiran represents a dual-mechanism approach designed to disrupt the HDV life cycle at multiple intervention points. The therapy is administered monthly as two separate sequential subcutaneous injections, targeting both viral entry and the sustained presence of hepatitis B surface antigen (HBsAg) that enables ongoing HDV replication.
Tobevibart Mechanism
Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting HBsAg. The antibody is designed to inhibit the entry of both hepatitis B and hepatitis delta viruses into hepatocytes while reducing circulating viral and subviral particles in the blood. Developed using Vir Biotechnology's proprietary monoclonal antibody discovery platform, tobevibart features an engineered Fc domain to enhance immune engagement and clearance of HBsAg immune complexes. The antibody also incorporates Xencor's Xtend™ technology to extend its half-life.
Elebsiran Mechanism
Elebsiran, licensed from Alnylam Pharmaceuticals (搜索), is an investigational small interfering ribonucleic acid (siRNA) targeting hepatitis B virus. The siRNA is designed to degrade hepatitis B virus RNA transcripts and limit HBsAg production, addressing the sustained antigen presence that facilitates ongoing HDV replication.
Company Profile
Vir Biotechnology operates as a clinical-stage biopharmaceutical company focused on developing medicines for serious infectious diseases and cancer by enhancing immune system function. Beyond chronic hepatitis delta, the company's clinical-stage portfolio includes multiple PRO-XTEN® dual-masked T-cell engagers targeting validated solid tumor indications, along with preclinical programs spanning infectious diseases and oncologic malignancies.