Invivyd Says Pemivibart Confers 84% Reduction In COVID-19 Risk, To Engage FDA With Expedited Pathway

(RTTNews) - 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.