Invivyd (IVVD)'s VYD2311 met all primary and secondary endpoints in its LIBERTY phase 3 trial compared to an mRNA-based COVID-19 vaccine, the company said Tuesday.
VYD2311's safety and tolerability were clinically and statistically superior to an mRNA-based COVID-19 vaccine, it added.
Invivyd said the trials' co-primary endpoints evaluated the proportion of subjects experiencing a treatment-emergent adverse event, injection site reaction, or hypersensitivity reaction over the first 6 days following dosing, and the proportion of subjects experiencing a systemic adverse event over the first 6 days after dosing.
The company said that VYD2311 in combination with an mRNA-based vaccine added substantially to vaccine-induced neutralizing titers.
Invivyd said it plans to submit a Biologics License Application under the US Food and Drug Administration's Accelerated Approval Program, pending results from the DECLARATION study, a companion study to LIBERTY.
Shares of Invivyd were down 2.6% in Tuesday's premarket activity.