Invivyd, Inc. (IVVD), a biopharmaceutical company, Wednesday announced that during its CANOPY phase 3 trial Pemivibart conferred an 84 percent reduction in the risk of becoming sick from COVID-19, compared to placebo. The formal evaluation was for six months, with a follow up of further six months.
Pemgarda or pemivibart is a half-life extended investigational monoclonal antibody.
Meanwhile, FDA acknowledged that the benefit of repeat doses of COVID-19 vaccine boosters for Americans is uncertain.
Invivyd said it plans to engage FDA shortly on an expedited pathway to develop
scalable COVID-19 prevention and treatment options.
Invivyed, in a follow-on said FDA leadership correctly identified gaps in the
modern understanding of COVID-19 vaccine booster efficacy and provided a
mechanism to resolve those gaps and move forward.
CANOPY Phase 3 clinical trial included a placebo-controlled, randomized
cohort of average Americans who are at risk of acquiring SARS-CoV-2 due to
regular unmasked face-to-face interactions in indoor settings.
According to Invivyd, Pemgarda has demonstrated in vitro neutralizing activity
against major SARS-CoV-2 variants, and it targets the SARS-CoV-2 spike protein receptor binding domain
thereby inhibiting virus attachment to the human ACE2 receptor on host cells.
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