Invivyd, Inc. announced its intention to submit an emergency use authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for pemivibart for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people utilizing a rapid immunobridging pathway. This immunobridging pathway leverages a similar approach Invivyd used to achieve its current EUA for PEMGARDA (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and was aligned in principle with the FDA. The immunobridging pathway for COVID-19 treatment is enabled by data from the Phase 2/3 clinical trial (STAMP) of adintrevimab, the prototype monoclonal antibody (mAb), for the treatment of COVID-191 and data from the ongoing CANOPY Phase 3 clinical trial of pemivibart for PrEP of COVID-19.

The potential COVID-19 treatment EUA request would focus on the critical treatment needs of people in the U.S. who have moderate-to-severe immune compromise and for whom alternative COVID-19 treatment options are not clinically appropriate or accessible. Subsequent to the anticipated submission of an EUA request, Invivyd plans to initiate a compact clinical trial focused on confirmatory safety, pharmacokinetics (PK), and clinical virology. Observational studies have demonstrated that people who are immunocompromised continue to be disproportionally impacted by COVID-19-related hospitalizations and death.2-3 In addition to small molecule treatment options, where appropriate a monoclonal antibody may be a highly attractive option to alter the course of established infection.