US-based clinical-stage biopharmaceutical company Visterra has commenced its Phase IIa clinical trial of VIS410 to treat hospitalised patients with influenza A.
VIS410 is a monoclonal antibody that targets all strains of influenza A and is indicated to treat hospitalised patients with influenza A.
It targets a specific epitope, generally referred to as a Hierotope, on hemagglutinin, which is a surface protein of influenza viruses used for binding and entry into cells.
VIS410 inhibits fusion of the influenza virus with host cell membranes by binding to hemagglutinin and resulting in the end of the viral replication cycle.
Funded by the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), the Phase IIa clinical trial is being conducted on a global basis that will examine about 150 ambulatory patients diagnosed with influenza A.
Influenza is an infectious disease that triggers both benign and malignant symptoms such as rapidly progressive pneumonia, respiratory failure and, in some cases, death.
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The severity of this disease is mostly observed in high-risk groups, including infants, pregnant women, the elderly, patients with underlying medical conditions, and patients with disease or treatment-related immunosuppression.
The patients enrolled in the trial will be divided into one of the three arms of the study and administered with dosages of 2,000mg and 4,000mg of VIS410 or placebo.
The study is primarily focused on establishing the safety and tolerability of VIS410, and its secondary endpoints are to determine clinical symptoms of influenza, virology and pharmacokinetics of VIS410.