Vir reports full viral suppression in Phase 2 SOLSTICE trial and plans mid‑2027 FDA filing
Vir Biotechnology announced that all 28 patients in its Phase 2 SOLSTICE trial achieved undetectable hepatitis delta virus RNA after 96 weeks of treatment with elebsiran and tobevibart. An exploratory analysis showed that the 10 patients who stopped therapy all maintained a sustained virologic response, with seven reaching SVR24 and one reaching SVR48. The company said the data, together with Phase 3 ECLIPSE results, will support a U.S. FDA submission planned for mid‑2027. The regimen holds U.S. Breakthrough Therapy and Fast Track designations and European PRIME and orphan drug status.
Why it matters
The company expects the combined trial data to form the basis of a global regulatory filing in mid‑2027, which could lead to the first approved therapy for chronic hepatitis delta. Analysts noted the strong trial outcomes drove a 15.23% pre‑market share rise, reflecting market optimism about a potential new product.
Key facts
- 1All 28 patients in the SOLSTICE trial had undetectable HDV RNA after 96 weeks of treatment. tradingview.com
- 2Ten patients who discontinued treatment all achieved SVR12; seven reached SVR24 and one reached SVR48. finance.yahoo.com
- 3Vir plans a U.S. FDA submission in mid‑2027 using data from the SOLSTICE and ECLIPSE programs. finance.yahoo.com
- 4The regimen has U.S. Breakthrough Therapy and Fast Track designations and European PRIME and orphan drug designations. rttnews.com
- 5Norgine holds exclusive commercialization rights for elebsiran and tobevibart in Europe, Australia and New Zealand, pending marketing authorizations. finance.yahoo.com
- 6Vir shares rose 15.23% in pre‑market trading to $14.07. rttnews.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.