Vir Biotechnology Completes Enrollment of Phase 2 Chronic Hepatitis Delta SOLSTICE Trial Ahead of Schedule

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that its Phase 2 SOLSTICE clinical trial evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta (CHD) virus has completed enrollment of its current cohorts one month earlier than anticipated. This includes over 60 participants in two additional cohorts – one evaluating tobevibart given every 2 weeks and the other evaluating the combination of tobevibart and elebsiran given every 4 weeks. Initial data are expected in the second quarter of 2024.

“The swift completion of enrollment ahead of expectations reflects the strong patient and physician interest being generated, and the urgent need for new treatment options for the millions of underserved hepatitis delta patients,” said Carey Hwang, M.D., Ph.D., Vir’s Senior Vice President, Clinical Research. “We are proud of the continued progress towards our goal of developing a safe and efficacious chronic therapy to address the significant treatment gap and look forward to reporting additional data on these participants this year.”

Of the participants dosed, approximately 50% have compensated cirrhosis. In the second quarter, the Company expects to report additional 12-week treatment data on 30 participants (15 per regimen) and 24-week treatment data on 20 participants (10 per regimen). Additional 24-week treatment data for all participants is expected in the fourth quarter of 2024.

SOLSTICE is a Phase 2 multi-center, open-label trial designed to evaluate the safety, tolerability, and efficacy of tobevibart and elebsiran in adult participants (age 18 to 69) with CHD infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Depending on the cohort, trial participants are receiving multiple doses of tobevibart and elebsiran as either monotherapy or in combination administered via subcutaneous injection for up to 88 weeks. The primary endpoints of the trial are the proportion of study participants achieving either a ≥ 2log10 decrease in HDV RNA compared to baseline or HDV RNA less than the limit of detection and normalization of alanine transaminase (ALT) at Week 24.