Invivyd's VYD2311 Meets Primary Goals in Head-to-Head mRNA Vaccine Trial

MT Newswires Live
Sep 29

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.

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