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Vir Biotechnology Announces Initiation of Phase 2 Clinical Trial Evaluating VIR-2218, Selgantolimod and Nivolumab for the Treatment of Chronic Hepatitis B Virus Infection
– Trial to evaluate antigen suppression combined with immunomodulation as a functional cure regimen for chronic HBV – SAN FRANCISCO, Dec. 09, 2021 (GLOBE
About this update from Vir Biotechnology, Inc.
[{"type":"text","content":"– Trial to evaluate antigen suppression combined with immunomodulation as a functional cure regimen for chronic HBV – SAN FRANCISCO, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating novel therapeutic combinations for the treatment of chronic hepatitis B virus (HBV) infection. The multi-arm trial, which is being conducted in collaboration with Gilead Sciences, Inc., is assessing various combinations of VIR-2218, Vir’s investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi); selgantolimod (GS-9688), Gilead Sciences’ investigational TLR-8 agonist; and nivolumab, an approved PD-1 inhibitor, in both nucleos(t)ide (NUC)-suppressed patients and viremic patients. Patients with HBV treatment experience also may receive tenofovir alafenamide fumarate (TAF). “For the majority of patients with chronic HBV, a functional cure will likely require a sustained reduction in hepatitis B surface antigen and restoration of the immune response,” said Carey Hwang, MD, PhD, senior vice president, clinical research, head of chronic infection for Vir Biotechnology. “We believe the combination of VIR-2218 and two immunomodulatory agents has the potential to improve the HBV-specific immune response and possibly achieve a functional cure. With the initiation of this trial, Vir now has four ongoing HBV trials evaluating VIR-2218, the foundation of our combination approaches, with other immunomodulatory agents as part of our ongoing pursuit of a functional cure.” The multi-center, open-label Phase 2 clinical trial is designed to evaluate the safety, tolerability and efficacy of various combinations of VIR-2218, selgantolimod, nivolumab and TAF in adults with chronic HBV. The trial will enroll approximately 120 patients ages 18 to 65 who are either viremic or are virally suppressed on an approved HBV nucleos(t)ide reverse transcriptase inhibitor. Patients who are hepatitis B e antigen (HBeAg)-positive (an indicator of acute viral replication), as well as those who are HBeAg-negative, will be enrolled. The primary efficacy endpoint is the proportion of patients who achieve a functional cure (defined as HBsAg loss and HBV DNA","length":2635,"tagName":"div"}]