Vir Biotechnology Announces First Patient Dosed in the Phase 2 SOLSTICE Trial Evaluating VIR-2218 and VIR-3434 for the Treatment of Chronic Hepatitis D Virus Infection
– Impacting more than 12 million people globally, HDV is the most aggressive form of viral hepatitis –
– Novel combination strategy designed to
SAN FRANCISCO, Sept. 22, 2022 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has been dosed in the Phase 2 SOLSTICE clinical trial evaluating VIR-2218 and VIR-3434 as monotherapy and in combination for the treatment of people living with chronic hepatitis D virus (HDV), which occurs as a simultaneous co-infection or super-infection alongside hepatitis B virus (HBV). HDV infection, the most aggressive form of viral hepatitis, increases the risk of poor outcomes, including liver cancer and death, compared with HBV alone.
VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) that diminishes the level of all HBV proteins in vitro, including hepatitis B surface antigen, a protein necessary to create infectious HDV virions. VIR-3434 is an investigational hepatitis B surface antigen targeting monoclonal antibody designed to remove both HBV and HDV virions from the blood and block the entry of these viruses into liver cells. VIR-2218 and VIR-3434 are currently being evaluated for the treatment of HBV in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial. Previously reported results from Part A of the MARCH trial demonstrated that the combination of VIR-3434 and VIR-2218 resulted in an approximate 3 log decline in hepatitis B surface antigen (HBsAg).
“Globally, more than 12 million people are living with HDV, and with no approved therapies available in the United States, there is an urgent need for the development of novel treatment strategies that will improve outcomes for patients,” said Carey Hwang, M.D., Ph.D., Vir’s senior vice president, clinical research, head of chronic infection. “Recent research suggests that reducing HDV viremia, by preventing virion formation as well as facilitating virion removal, in conjunction with blocking HDV virion entry into liver cells could be effective in suppressing chronic HDV infection. The initiation of SOLSTICE, our first clinical trial in HDV, is an important milestone as we advance our broad therapeutic portfolio for viral hepatitis, which also includes the pursuit of a functional cure for chronic HBV infection.”
Design of the Phase 2 SOLSTICE Trial
About Chronic Hepatitis D
About Chronic Hepatitis B
About Vir Biotechnology
Contacts: Investors Heather Rowe Armstrong VP, Investor Relations [email protected] +1-415-915-4228 Media Carly Scaduto Senior Director, Media Relations [email protected] +1-314-368-5189