Invivyd (IVVD) announced full Phase 1/2 clinical data for VYD2311, a next-generation monoclonal antibody candidate designed to prevent and treat COVID-19. The Phase 1/2 study of VYD2311 was a randomized, double-blind, first-in-human clinical trial evaluating the safety and clinical pharmacokinetic profile of VYD2311 in 40 subjects across multiple routes of administration and dose levels for a single dose, and includes VYD2311 dosed intravenously, intramuscularly, and subcutaneously in four cohorts of 10 participants each, randomized 8:2 to receive drug or placebo. This range of ROAs and doses was tested to provide maximum flexibility in designing registrational pathways for both COVID-19 prophylaxis and treatment, while retaining a high barrier to resistance in the form of doses expected to accommodate significant evolutionary changes in SARS-CoV-2 viruses.
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