Vir Biotechnology, Inc. (Nasdaq: VIR), today announced new, expanded data from the Phase 2 SOLSTICE trial evaluating monthly subcutaneous administration of elebsiran and tobevibart in adults with chronic hepatitis delta (CHD). These data include new analyses presented in oral sessions at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2026, in Denver, Colorado.
“We are seeing rapid viral suppression that deepens over time, alongside improvement in liver fibrosis and function, giving us a more complete view of what sustained control of HDV could mean for patients,” said Tarik Asselah, M.D., Ph.D., Professor of Hepatology at the Hôpital Beaujon, APHP, Clichy, France, and at the University of Paris-Cité, and Head of the unit Viral Hepatitis UMR1149 at INSERM, France. “Furthermore, the profound antiviral potency with patients achieving virus undetectability provides optimism for the potential of elebsiran and tobevibart to offer finite treatment. As the clinical experience with elebsiran and tobevibart continues to grow, so does our optimism about the possibility to meaningfully change the trajectory of this serious disease.”
Additional Week 96 data from the Phase 2 SOLSTICE trial show that treatment with elebsiran and tobevibart drove rapid HDV RNA suppression, with 100% (28/28) of patients who completed Week 96 of combination therapy reaching undetectable viremia.
Deep virologic response to undetectable levels was accompanied by encouraging findings across measures of liver health. Among patients with paired liver stiffness measurements, 89% (24/27) had improved or stable liver stiffness at Week 96. Liver stiffness is a noninvasive measure associated with liver inflammation and fibrosis, and its improvement or stabilization alongside sustained HDV RNA suppression provides additional insight into the potential impact of treatment on the underlying liver disease.
With extended follow-up, the regimen continued to be generally well-tolerated. Adverse events were mild to moderate with no study drug-related discontinuations or serious adverse events.
SOLSTICE Exploratory Analysis of Finite Treatment
Beyond the expanded SOLSTICE data presented at AASLD, new and early exploratory analyses suggest curative potential of the regimen. The SOLSTICE trial design allows for exploration of the durability of profound viral suppression following treatment discontinuation. Patients who achieve and maintain undetectable virus for at least 96 weeks are eligible to discontinue elebsiran and tobevibart treatment and are followed to assess for sustained viral response (SVR). SVRx is defined at the number of weeks (x) after last dose.
Ten patients, 7 of whom are cirrhotic, chose to discontinue treatment, with follow-up assessment ranging from 12 to 48 weeks as of the data cutoff. All 10 patients achieved SVR12. Among those reaching later follow-up timepoints, 7 achieved SVR24 and 1 achieved SVR48. All 10 patients maintained stable ALT levels following treatment discontinuation with no viral rebound or ALT flares observed in any of the patients. All 10 patients are continuing follow-up to later time points.
“These preliminary findings show the potential for a finite treatment approach that goes beyond suppressing HDV to potentially achieving cure,” said David Liu, Chief Medical Officer of Vir Biotechnology. “For patients who have faced the prospect of living with this chronic disease, that possibility could fundamentally change what is achievable in hepatitis delta.”
The elebsiran and tobevibart regimen is being evaluated in the ECLIPSE registrational program, and the company announced topline Phase 3 results from the pivotal ECLIPSE 1 trial earlier today showing the trial met all of its study endpoints. Data from all three trials will support a comprehensive global regulatory filing package planned for U.S. FDA submission in mid-2027.
The significant unmet need in CHD and the potential for the combination of elebsiran and tobevibart to provide a differentiated treatment option has been recognized by the U.S. Food and Drug Administration (FDA) with Breakthrough Therapy and Fast Track designations, and by the European Medicines Agency (EMA) with Priority Medicines (PRIME) and orphan drug designations.
In December 2025, Vir Biotechnology entered into an exclusive licensing agreement with Norgine, under which Norgine will be responsible for the commercialization of elebsiran and tobevibart in Europe, Australia and New Zealand, subject to receipt of the necessary marketing authorizations.
Conference Call
Vir Biotechnology will host a conference call to discuss the ECLIPSE 1 topline results and expanded SOLSTICE data at 8:30 a.m. ET / 5:30 a.m. PT on Monday, November 9. A live webcast will be available at https://investors.vir.bio and will be archived for 30 days.
About the ECLIPSE Registrational Program
ECLIPSE is a registrational program to evaluate the safety and efficacy of elebsiran in combination with tobevibart in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to delayed treatment or bulevirtide. ECLIPSE 1 (NCT06903338) is a Phase 3 trial evaluating the safety and efficacy of elebsiran in combination with tobevibart compared to delayed treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 (NCT07128550) is a Phase 3 trial evaluating the efficacy and safety of switching to elebsiran and tobevibart in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies. ECLIPSE 3 (NCT07142811) is a pivotal head-to-head trial evaluating combination elebsiran and tobevibart compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets.
About Elebsiran and Tobevibart
Elebsiran and tobevibart are investigational agents being evaluated as a novel combination regimen administered monthly as two separate sequential subcutaneous injections for the treatment of chronic hepatitis delta (CHD). The combination is designed to disrupt the hepatitis delta virus (HDV) life cycle at multiple points by addressing both viral entry and the sustained presence of hepatitis B surface antigen (HBsAg) that enables ongoing HDV replication.
Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) licensed from Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of HBsAg.
Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) targeting HBsAg. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary mAb discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life.
About Chronic Hepatitis Delta (CHD)
CHD is the most severe form of chronic viral hepatitis1 and was recently classified as carcinogenic by the International Agency for Research on Cancer.2 People living with the disease rapidly progress to cirrhosis, liver failure3 and liver-related death.1 Because ongoing hepatitis delta virus (HDV) replication drives disease progression, achieving undetectable virus, as defined by HDV RNA TND (target not detected), is considered an important virologic marker associated with improved clinical outcomes in CHD.4 Individuals with CHD who have detectable HDV RNA are at a higher risk of experiencing any liver-related event, including developing compensated and decompensated cirrhosis, hepatocellular carcinoma, liver transplantation and mortality, compared to patients with undetectable HDV RNA.4 There are currently limited approved treatments in the U.S. and globally.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of the elebsiran and tobevibart regimen to treat patients living with CHD and change the trajectory of the disease, including further exploration of the regimen as a finite treatment that can possibly achieve cure; Vir Biotechnology’s clinical development plans and expectations for the elebsiran and tobevibart regimen, including protocols for and enrollment into ongoing and planned clinical trials, target endpoints and data readouts, as well as plans for a U.S. FDA regulatory submission in mid-2027; Vir Biotechnology’s strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology’s planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology’s competitors, as well as changes in expected or existing competition; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Considerations and Limitations of the Finite Treatment Data
The SOLSTICE data described in this press release are preliminary and represent an interim snapshot of the first 10 patients who meet protocol-specified eligibility criteria and consent to treatment discontinuation. The finite treatment analysis is exploratory and is based on interim data that have not undergone a formal data cut. Accordingly, the participants and outcomes presented may not be representative of the broader SOLSTICE study population or of results that may be observed with additional participants or longer follow-up. Follow-up remains ongoing and incomplete, including with respect to potential delayed hepatic flares following treatment discontinuation, and safety data have not been fully assessed. The data remain subject to ongoing data review, cleaning and analysis and may change as the study continues. These data should not be interpreted as a complete assessment of the safety or efficacy of the investigational regimen or as establishing a sustained treatment-free response or cure.
Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
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