Invivyd reports positive Phase III safety results for COVID-19 antibody VYD2311

Invivyd has reported topline results from its Phase III LIBERTY study regarding VYD2311, an investigational low-dose intramuscular monoclonal antibody intended to prevent COVID-19. The study met its primary safety and tolerability objectives, demonstrating a statistically significant advantage over an mRNA COVID-19 vaccine during both six-day and 56-day follow-up periods.

Key findings indicated that participants receiving VYD2311 experienced a lower overall burden of adverse events compared to those receiving the vaccine. Specifically, injection-site reactions were substantially less common in the monoclonal antibody arm, with a risk difference of more than 60% compared to the vaccine-only group. Systemic symptoms, such as headache, chills, and fatigue, were also less frequent among VYD2311 recipients.

Based on these results, Invivyd plans to pursue an accelerated approval pathway with the U.S. Food and Drug Administration (FDA). While the LIBERTY study focused on safety and tolerability, the company is awaiting data from its ongoing DECLARATION study to further assess efficacy against symptomatic COVID-19.