Invivyd says VYD2311 safety beats mRNA vaccine in Phase 3 study

  • Invivyd reported LIBERTY Phase 3 results for VYD2311, Comirnaty and their combination.
  • VYD2311 produced 56.5% short-term events versus 91.4% for the mRNA vaccine.
  • Invivyd plans a Biologics License Application using LIBERTY and DECLARATION data.

Invivyd reported topline results from LIBERTY, a Phase 3 double-blind study of its investigational COVID-19 monoclonal antibody VYD2311, Comirnaty and their combination. Among 210 healthy adults aged 18 to 49, VYD2311 alone produced fewer short-term treatment-emergent adverse events than the mRNA vaccine, at 56.5% versus 91.4%, and maintained a lower rate over 56 days, at 60.9% versus 91.4%. Short-term systemic adverse events occurred in 44.1% of the VYD2311 group, 50.0% of the combination group and 68.1% of the vaccine-only group. No adverse event exceeded Grade 2, and no hypersensitivity or anaphylaxis occurred across the study. Adding VYD2311 to the vaccine increased total neutralizing titers by about 2.5 times over 56 days, while vaccine-derived titers remained identical to those from the vaccine-only arm after VYD2311 was removed from combination samples. Invivyd said it intends to seek a Biologics License Application through the FDA's Accelerated Approval Program using LIBERTY and DECLARATION data, while continuing randomized confirmatory clinical-event collection after approval. Shares were down 11.59% at $0.91 at publication, according to Benzinga Pro.

The information on this website is generated using AI and we cannot guarantee its accuracy. Please use it as reference information only.