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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

Business Wire•08/11/2026•16:15 ET
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Key Highlights

  • ➤Vir Biotechnology (VIR) met the ECLIPSE 1 Phase 3 primary endpoint with a 44% response rate.
  • ➤79% achieved undetectable HDV RNA at Week 48 versus 0% for delayed treatment.
  • ➤100% achieved virologic response at Week 48 versus 0% for delayed treatment.
  • ➤U.S. FDA submission package planned for mid-2027, pending ECLIPSE 2 and 3 data.
  • ➤ECLIPSE 2 and 3 data expected in the first quarter of 2027.

Expert Statements

Nancy Reau, Associate Director of Solid Organ Transplantation and Section Chief of Hepatology at Rush University Medical Center

“For people living with CHD, the goal is not simply to reduce the amount of virus, but to drive it to levels where it is no longer detectable since ongoing HDV replication drives liver disease progression.”

Nancy Reau, Associate Director of Solid Organ Transplantation and Section Chief of Hepatology at Rush University Medical Center

“The high number of participants who achieved undetectable virus and normalized ALT levels in ECLIPSE 1 shows that the combination regimen of elebsiran and tobevibart could offer a meaningful new treatment option for people living with this serious, progressive disease.”

Marianne De Backer, President and Chief Executive Officer of Vir Biotechnology

“Our ambition in hepatitis delta has always been to fundamentally change what patients can expect from treatment.”

Marianne De Backer, President and Chief Executive Officer of Vir Biotechnology

“These compelling ECLIPSE 1 results deliver on the potential for elebsiran’s and tobevibart’s complementary mechanisms to drive the virus to undetectable levels, potentially lowering the risk of progression to cirrhosis, liver cancer and liver-related mortality.”

Marianne De Backer, President and Chief Executive Officer of Vir Biotechnology

“We believe the robust viral suppression combined with the flexibility of monthly at-home or healthcare provider administration has the potential to position elebsiran and tobevibart as the best-in-disease treatment for hepatitis delta.”

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

* Trial met all Phase 3 endpoints and regimen is well-tolerated with all patients completing 48 weeks of treatment

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