Vir Biotechnology, Inc.announced new data from its robust hepatitis B virus (HBV) clinical trial program, including results from an ongoing Phase 2 clinical trial of VIR-2218, results from an ongoing Phase 1 clinical trial of VIR-3434 and preclinical data evaluating both investigational compounds as monotherapy and in combination. Data were presented in one oral and two poster presentations at the International Liver Congress™ (ILC) 2022, the Annual Meeting of the European Association for the Study of the Liver (EASL).
In summary, data presented at ILC demonstrated that a six-dose regimen of VIR-2218 provided greater and more durable reductions in hepatitis B surface antigen (HBsAg) than a two-dose regimen, with all participants achieving a >1 log10 IU/mL reduction during the trial. Phase 1 results evaluating VIR-3434 showed that a single dose (6 mg, 18 mg, 75 mg or 300 mg) resulted in a rapid reduction of HBsAg, with the largest and most durable response noted with the 300 mg dose. Finally, preclinical in vivo data demonstrated that the combination of both investigational compounds resulted in greater HBsAg reductions than either compound alone.
“The data presented at the International Liver Congress 2022 continue to indicate that our therapeutic strategy of combining an antiviral with an immunomodulator to restore immunologic control in patients with chronic HBV is additive and offers the potential for a functional cure,” said Carey Hwang, M.D., Ph.D., Vir’s senior vice president, clinical research, head of chronic infection. “As we continue to evaluate VIR-2218 and VIR-3434, we are encouraged by the potential of these two investigational medicines alone and in combination. These data, alongside the anticipated initiation of Part B of the MARCH trial by the end of June, are important milestones in our broad HBV portfolio for which we expect multiple data readouts throughout 2022 and 2023.”
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As part of its ongoing efforts to advance its broad HBV portfolio, Vir expects to dose the first patient in Part B of the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial evaluating VIR-2218 in combination with VIR-3434 for 24 and 48 weeks, and in combination with interferon, by the end of June. Previously reported results from Part A demonstrated that VIR-3434 combined with VIR-2218 provided an additional 2 log decline in HBsAg loss over the 3 log decrease with VIR-2218 alone. No drug-related safety signals were observed. Additional data from Part A are expected later this year. However, with clinical trial sites in Ukraine and Moldova, the Company is continuing to monitor the war in Ukraine for any potential impact on timing.