Hepatitis B Vaccine (Recombinant)

Vir Biotechnology's SOLSTICE Phase 2 trial showed 100% virologic response and rapid HDV RNA suppression with tobevibart and elebsiran combination for CHD, with 80% achieving HDV RNA TND by Week 60. The Phase 3 ECLIPSE program is planned for 2025 to further evaluate this combination.

Vir Biotechnology announces positive results from SOLSTICE Phase 2 trial evaluating tobevibart and elebsiran for chronic hepatitis delta, achieving 100% virologic suppression and rapid HDV RNA suppression. The combination is well-tolerated, with no severe AEs or discontinuations. Phase 3 ECLIPSE program to begin in 2025.

Vir Biotechnology's SOLSTICE Phase 2 trial shows 100% virologic suppression with tobevibart and elebsiran combination for chronic hepatitis delta (CHD), with 80% achieving undetectable HDV RNA by Week 60. The combination is well-tolerated, and a Phase 3 ECLIPSE program is planned for 2025.

EMA's COMP issues positive opinion on orphan drug designation for tobevibart and elebsiran in chronic hepatitis delta, based on Phase 2 SOLSTICE trial data. This follows U.S. FDA fast track designation, highlighting potential in treating CHD.

Vir Biotechnology receives positive opinion from EMA for orphan drug designation of tobevibart and elebsiran in treating chronic hepatitis delta, following FDA fast track designation in June 2024. The orphan designation could provide 10 years of market exclusivity in the EU upon approval.

Barinthus Biotherapeutics reports Phase IIb HBV003 trial data showing 8 participants with complete hepatitis B surface antigen (HBsAg) loss and 2 achieving functional cure. The trial, ongoing with 121 participants, suggests stronger responses in patients treated with VTP-300 and low-dose nivolumab. Preliminary safety data indicates the combination is well-tolerated. The data will be presented at the AASLD 2024 liver meeting.

Vir Biotechnology announced end-of-treatment data from MARCH Phase 2 study evaluating tobevibart and elebsiran combinations for chronic hepatitis B, showing promising HBsAg loss rates in participants with low baseline HBsAg.

New data from Phase 2a IM-PROVE II trial shows significant HBsAg declines in participants receiving imdusiran, VTP-300, and low-dose nivolumab, with 23% achieving HBsAg loss by Week 48.