Visterra has announced that their lead product candidate VIS410, intended to treat hospitalized patients with influenza A, has been granted Fast Track designation by the Food and Drug Administration (FDA).

VIS410, a monoclonal antibody, is being developed for single-dose administration to target all known strains of influenza A. It is directed against a specific epitope, the ‘Hierotope’, on hemagglutin, which is a surface protein of influenza viruses used for binding entry into cells. VIS410 is designed to prevent fusion of the influenza virus with host cell membranes by binding to hemagglutinin and thereby terminating the viral replication cycle.

“We are developing VIS410 as a single-dose treatment, and plan to initiate a Phase 2b clinical trial in hospitalized patients with influenza A in early 2018,” said Brian J.G. Pereira, MD, president and CEO of Visterra. The company is currently conducting a Phase 2a trial with funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.

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VISA410 was developed using Visterra’s Hierotope platform which identifies disease targets and subsequently designs precision antibody biologics against them.

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