Vir Biotechnology reports Phase 3 hepatitis delta trial meets primary and key secondary endpoints
Vir Biotechnology announced that its Phase 3 ECLIPSE 1 trial of elebsiran and tobevibart met the primary endpoint, with 44% of treated patients achieving undetectable HDV RNA and normalized ALT at Week 48, and 79% achieving undetectable virus at the same time point. The 124‑patient study also showed 85% of cirrhotic patients virus‑free. The company plans a global regulatory filing for the U.S. FDA in mid‑2027 and expects data from ECLIPSE 2 and 3 in Q1 2027.
Why it matters
The FDA filing timeline creates a multi‑year revenue runway, and the company’s cash balance of $901.3 million should fund operations into the second half of 2028. Successful trial data positions the therapy for potential market entry, which could drive significant future sales.
Key facts
- 1The ECLIPSE 1 trial enrolled 124 patients. quantisnow.com
- 244% of treated patients met the primary endpoint of undetectable HDV RNA plus ALT normalization at Week 48. quantisnow.com
- 379% of treated patients had undetectable virus at Week 48. quantisnow.com
- 485% of cirrhotic patients were virus‑free at Week 48. finance.yahoo.com
- 5Vir plans a comprehensive U.S. FDA submission in mid‑2027. quantisnow.com
- 6Vir reported approximately $901.3 million in cash, cash equivalents and investments at Sept. 30, sufficient to fund operations into the second half of 2028. mugglehead.com
Summary written by AlphAI AI Desk from 18 of 18 sources. Not investment advice. Figures are as stated by the linked sources.