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Vir Biotechnology Presents Positive Chronic Hepatitis Delta Clinical Trial Data and Announces Initiation of Phase 3 Registrational Program
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11/18/2024
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- Monthly tobevibart and elebsiran combination achieves rapid 100% virologic suppression at Week 24, sustained through Week 60 -
- Undetectable HDV RNA in 41% of participants at Week 24, increasing to 64% by Week 36 and up to 80% by Week 60 across cohorts -
- Combination well-tolerated: no treatment-related severe AEs, treatment-related discontinuations or ALT flares -
- Following a recent FDA meeting, Phase 3 ECLIPSE registrational program to begin in the first half of 2025 -
SAN FRANCISCO--(BUSINESS WIRE)-- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced positive results from the SOLSTICE Phase 2 clinical trial evaluating tobevibart alone, or in combination with elebsiran, in people with chronic hepatitis delta (CHD). The most-advanced and potential first-of-its-kind investigational human monoclonal antibody and siRNA combination dosed monthly achieved 100% virologic response and rapid hepatitis delta virus (HDV) RNA suppression. HDV RNA below the lower limit of quantification (< LLOQ), target not detected (TND), the best measure that the virus is cleared from the body, was achieved in 41% (13/32) of participants at Week 24 rising to 64% (14/22) of participants by Week 36. In a cohort that reached Week 60, 80% (4/5) achieved HDV RNA TND.
https://investors.vir.bio/news/news-details/2024/Vir-Biotechnology-Presents-Positive-Chronic-Hepatitis-Delta-Clinical-Trial-Data-and-Announces-Initiation-of-Phase-3-Registrational-Program/default.aspx
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