Vir Biotech Highlights Significant Viral Suppression in Advanced Liver Disease Study
Vandana Singh 3 hours ago
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Vir Biotechnology reported positive Phase 3 ECLIPSE 1 data for its chronic hepatitis delta treatment ahead of planned 2027 FDA filings.
Vir Biotechnology Inc. (NASDAQ:VIR) on Sunday shared positive topline findings from its pivotal Phase 3 ECLIPSE 1 study evaluating monthly subcutaneous elebsiran and tobevibart in adults with chronic hepatitis delta.
The company delivered the results at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2026
Robust Efficacy Across Advanced Disease
The ECLIPSE 1 trial enrolled 124 patients with advanced disease.
Investigators randomized participants two-to-one to monthly subcutaneous elebsiran and tobevibart or delayed therapy, with the delayed cohort initiating treatment at Week 12.
The dual regimen met the study’s primary endpoint, delivering a 44% response rate for undetectable virus alongside alanine aminotransferase normalization at Week 48.
In contrast, the delayed control group posted a 0% response rate at Week 12.
The trial also achieved its key secondary endpoint, as 79% of treated participants attained undetectable virus at Week 48 compared to 0% in the delayed arm.
High suppression rates occurred irrespective of cirrhosis status, reaching 85% in cirrhotic patients and 73% in non-cirrhotic patients.
Furthermore, the combination achieved a 100% virologic response rate, 53% enzyme normalization, and reduced surface antigen levels below 10 IU/mL in 95% of patients.
Favorable Safety And Next Regulatory Steps
The regimen demonstrated a favorable safety profile without treatment interruptions or discontinuations. Investigators recorded one Grade 3 adverse event involving a transient neutrophil drop that resolved within 15 days.
Mild to moderate flu-like symptoms after the initial dose represented the most frequent side effect, resolving within 24 to 48 hours.
Vir plans to combine ECLIPSE 1 findings with upcoming data from the ECLIPSE 2 and ECLIPSE 3 trials, expected in the first quarter of 2027.
These studies will support a comprehensive global regulatory filing package slated for U.S. Food and Drug Administration submission in mid-2027.
Under a December 2025 licensing deal, Norgine holds commercialization rights in Europe, Australia, and New Zealand.
VIR Price Action: Vir Biotechnology shares were up 14.66% at $13.13 at the time of publication on Monday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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