Vir Biotechnology, Inc. filed a Form 8-K on November 9, 2026, disclosing topline results from its pivotal Phase 3 ECLIPSE 1 clinical trial and expanded Week 96 data from the Phase 2 SOLSTICE study, both evaluating elebsiran and tobevibart in adults with chronic hepatitis delta.

Key Highlights

  • Primary endpoint met: 44% of patients receiving elebsiran and tobevibart achieved undetectable virus plus ALT normalization at Week 48, versus 0% in the delayed treatment group at Week 12 (p<0.0001).
  • Key secondary endpoint met: 79% of patients in the treatment arm achieved undetectable virus (HDV RNA TND) at Week 48, compared with 0% in the delayed treatment group.
  • ECLIPSE 1 enrollment: The trial enrolled 124 patients randomized 2:1 across a broad and diverse chronic hepatitis delta population, including patients with advanced disease.
  • SOLSTICE Week 96 data: 100% (28/28) of patients who completed Week 96 of combination therapy reached undetectable viremia, with 89% (24/27) showing improved or stable liver stiffness.
  • Finite treatment exploratory analysis: All 10 patients who discontinued treatment achieved SVR12; 7 achieved SVR24 and 1 achieved SVR48, with no viral rebound or ALT flares observed.
  • Safety profile: One Grade 3 treatment-related adverse event was reported in ECLIPSE 1 (neutrophil count decrease, which resolved in 15 days), with no treatment interruptions or discontinuations.

ECLIPSE 1 and SOLSTICE Results Presented at AASLD 2026

According to the filing, data from the ongoing Phase 3 ECLIPSE 1 clinical trial were presented in an oral session at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting in Denver, Colorado on November 8, 2026. ECLIPSE 1 enrolled 124 patients randomized 2:1 to receive monthly subcutaneous elebsiran and tobevibart or delayed treatment, with the delayed treatment group initiating therapy at Week 12. The trial's primary endpoint, undetectable virus defined as HDV RNA target not detected (TND) plus alanine aminotransferase (ALT) normalization, was met with a 44% response rate at Week 48 versus 0% in the delayed treatment group (p<0.0001). The key secondary endpoint of undetectable virus alone was achieved by 79% of treated patients. The filing further disclosed that HDV RNA TND was achieved in 85% of cirrhotic patients (n=46) and 73% of non-cirrhotic patients (n=37).

Expanded Week 96 data from the Phase 2 SOLSTICE study, also presented at AASLD on November 8, 2026, showed that 100% (28/28) of patients completing Week 96 of combination therapy reached undetectable viremia, the company disclosed. Additionally, 89% (24/27) of patients with paired liver stiffness measurements had improved or stable liver stiffness at Week 96. The filing noted the regimen "continued to be generally well-tolerated" with adverse events described as mild to moderate and no study drug-related discontinuations or serious adverse events.

The filing also presented an exploratory finite treatment analysis from SOLSTICE. Ten patients, 7 of whom are cirrhotic, chose to discontinue treatment, with follow-up ranging from 12 to 48 weeks as of the data cutoff. The company cautioned that "the finite treatment analysis is exploratory and is based on interim data that have not undergone a formal data cut," and that the 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, Inc. trades on the Nasdaq Global Select Market under the symbol NASDAQ:VIR.

What Was Disclosed

Vir Biotechnology filed an 8-K reporting topline Phase 3 ECLIPSE 1 trial results and updated Phase 2 SOLSTICE data for elebsiran and tobevibart in chronic hepatitis delta, including primary and secondary endpoint outcomes and an exploratory finite treatment analysis, as of November 8, 2026.