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Invivyd Announces General Alignment with U.S. FDA on a Repeatable, Expedient Emergency Use Authorization Pathway for the Prevention and Treatment of Symptomatic COVID-19, Based on Compact Clinical Programs to Establish Safety and Immunobridging for Se...
Invivyd Announces General Alignment with U.S. FDA on a Repeatable, Expedient Emergency Use Authorization Pathway for the Prevention and Treatment of
About this update from Invivyd, Inc.
[{"type":"text","content":"Invivyd Announces General Alignment with U.S. FDA on a Repeatable, Expedient Emergency Use Authorization Pathway for the Prevention and Treatment of Symptomatic COVID-19, Based on Compact Clinical Programs to Establish Safety and Immunobridging for Serial Monoclonal Antibodies \n Newly outlined pathway provides a practical, expedient, repeatable immunobridging approach to potential emergency use authorization of serial, novel monoclonal antibodies (mAbs) to prevent and treat COVID-19Pathway provides for the establishment of a master, registrational clinical trial protocol that is anticipated to streamline the evaluation of new mAbs in compact clinical programsUtilizing this framework, Invivyd plans to rapidly move towards a registrational clinical trial of VYD2311 that evaluates intravenous (IV) and potentially other routes of administration WALTHAM, Mass., May 31, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced general alignment with the U.S. Food and Drug Administration (FDA) on an expedient, repeatable immunobridging pathway to future potential emergency use authorizations (EUAs) for serial, novel monoclonal antibodies (mAbs) for the prevention and treatment of symptomatic COVID-19. Coupled with Invivyd’s proprietary mAb technology platform and engineering capabilities, this pathway provides the company with the opportunity to rapidly, efficiently, and durably deliver high value medicines that prevent and treat symptomatic COVID-19 in vulnerable populations. This pathway provides for the establishment of a master, registrational clinical trial protocol that could obviate the need to submit a new protocol for the evaluation of each new mAb, streamlining the process required to evaluate new mAbs in compact clinical programs envisioned to include hundreds of participants (e.g., 300-600) exposed to a new mAb, with the specific number of exposures to be determined in consultation with the FDA. This compact, repeatable immunobridging pathway is similar to the approach Invivyd used to obtain an EUA for PEMGARDA™ for pre-exposure prophylaxis (PrEP) but would leverage a more efficient route to obtaining the safety and pharmacokinetics (PK) data that could support future potential EUA requests. The direct clinical...