Vir Biotechnology to Present New Data from Its Ongoing Phase 2 Chronic Hepatitis Delta and B Trials Today at AASLD’s The Liver Meeting 2023

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced it will be presenting new data from its ongoing Phase 2 SOLSTICE and MARCH trials evaluating the potential clinical impact that VIR-3434, an investigational monoclonal antibody (mAb), and VIR-2218, an investigational small interfering ribonucleic acid (siRNA), could have for chronic hepatitis delta (CHD) and chronic hepatitis B (CHB) patients at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting. These include one late-breaking oral presentation and one late-breaking poster presentation.

Phase 2 SOLSTICE (CHD)

Initial data to be presented in a late-breaking oral presentation from the ongoing Phase 2 SOLSTICE clinical trial demonstrated that after three subcutaneous doses of either VIR-3434 or VIR-2218 monotherapy, six patients rolled over into combination therapy with VIR-3434 and VIR-2218. Of the five participants receiving combination therapy who have reached Week 12, 100% had HDV RNA less than the lower limit of quantification¹ with 80% (4 of 5) having undetectable HDV RNA². To date, no participants receiving the combination therapy or VIR-3434 monotherapy have experienced ALT elevations relative to their baseline. ALT elevations >250 IU/ml were observed in two participants who received VIR-2218 monotherapy.

“Chronic hepatitis delta is the most aggressive form of viral hepatitis. There are few treatment options for people living with HDV infection. Undetectable HDV RNA is an important endpoint associated with clinical benefit. These early results from SOLSTICE are unprecedented, with 80% of participants being undetectable at Week 12 of combination therapy,” said Tarik Asselah, M.D., Ph.D., Professor of Hepatology at the Hôpital Beaujon, APHP, Clichy, France, and at the University of Paris, and Head of Viral Hepatitis at INSERM UMR1149, France. “If this result can be reproduced in a much larger group of participants, I believe this potentially once monthly therapy could be transformative for patients.”

“CHD impacts over 12 million people worldwide and approximately 100,000 people here in the United States,” said Phil Pang, M.D., Ph.D., Vir’s Executive Vice President, Chief Medical Officer. “This data highlights Vir’s commitment to developing a game-changing chronic suppressive therapy for this rare disease.”

The company expects to report additional SOLSTICE data for VIR-3434 + VIR-2218 in the second quarter of 2024. The Company is also evaluating VIR-3434 as monotherapy given twice monthly as part of the SOLSTICE trial.