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Vir Biotechnology Announces Primary Endpoint Met in Pivotal Phase 3 ECLIPSE 1 Trial for Elebsiran and Tobevibart in Chronic Hepatitis Delta

VIR
  • The ECLIPSE 1 Phase 3 trial met all endpoints with a regimen of elebsiran & tobevibart that was well-tolerated, allowing all 124 patients to complete 48 weeks of treatment.
  • 100% of patients achieved a virologic response at Week 24, while 79% reached undetectable virus (HDV RNA TND) at Week 48.
  • The primary endpoint of undetectable virus plus ALT normalization was achieved by 44% of patients in the treatment group versus 0% in the delayed treatment group.
  • Undetectable virus was observed across diverse patient populations, including 85% of cirrhotic patients & 73% of non-cirrhotic patients.
  • The regimen demonstrated a favorable safety profile with no treatment interruptions or discontinuations; the most common adverse event was mild flu-like symptoms.
  • Vir Biotechnology plans to submit a comprehensive regulatory filing package to the U.S. FDA in mid-2027, supported by data from ECLIPSE 1, ECLIPSE 2, & ECLIPSE 3 trials.
  • A conference call to discuss the ECLIPSE 1 results & expanded SOLSTICE Phase 2 data is scheduled for November 9, 2026, at 8:30 a.m. ET.
  • The U.S. FDA has granted Breakthrough Therapy & Fast Track designations, while the European Medicines Agency has granted Priority Medicines & orphan drug designations for the combination therapy.
  • An exclusive licensing agreement with Norgine was finalized in December 2025 for commercialization in Europe, Australia, & New Zealand.
  • Elebsiran is an investigational siRNA targeting HBV RNA transcripts, & tobevibart is a monoclonal antibody designed to inhibit viral entry & reduce HBsAg levels.