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Vir Biotechnology Announces Expanded Phase 2 SOLSTICE Data for Elebsiran and Tobevibart in Chronic Hepatitis Delta, Showing Deep and Sustained Viral Suppression, and Exploratory Finite Treatment Data

VIR
  • Phase 2 SOLSTICE trial data presented at AASLD The Liver Meeting showed 100% of participants (28/28) completing Week 96 of elebsiran & tobevibart combination therapy achieved undetectable HDV RNA.
  • Exploratory analysis indicated curative potential with 10/10 patients who discontinued treatment after 96 weeks of undetectable virus maintaining sustained viral response (SVR) for 12 to 48 weeks post-treatment.
  • Extended follow-up of the regimen demonstrated rapid HDV RNA suppression, with 89% of patients (24/27) showing improved or stable liver stiffness at Week 96.
  • The treatment was generally well-tolerated with mild to moderate adverse events, no study drug-related discontinuations, & no serious adverse events reported.
  • Vir Biotechnology announced topline Phase 3 ECLIPSE 1 trial results met all study endpoints, supporting a global regulatory filing package planned for U.S. FDA submission in mid-2027.
  • The elebsiran & tobevibart combination received Breakthrough Therapy & Fast Track designations from the FDA, & Priority Medicines & orphan drug designations from the EMA.
  • An exclusive licensing agreement with Norgine was established in December 2025 for commercialization of the therapy in Europe, Australia, & New Zealand.
  • Vir Biotechnology will host a conference call on November 9, 2026, at 8:30 a.m. ET to discuss ECLIPSE 1 topline results & expanded SOLSTICE data.
  • The ECLIPSE registrational program includes three Phase 3 trials evaluating the safety & efficacy of elebsiran & tobevibart compared to delayed treatment or bulevirtide.
  • Elebsiran is an investigational siRNA designed to degrade HBV RNA transcripts, while tobevibart is a monoclonal antibody designed to inhibit viral entry & reduce HBsAg levels.
  • Chronic Hepatitis Delta (CHD) is a severe form of viral hepatitis classified as carcinogenic, with limited approved treatments currently available globally.