Invivyd reports favorable Phase 3 tolerability results and outlines filing plans

Invivyd ($IVVD) said its investigational antibody VYD2311 met the primary and key secondary safety endpoints in LIBERTY, a randomized study involving 210 healthy adults aged 18–49. Within six days, 56.5% of antibody recipients reported an adverse event, injection-site reaction or hypersensitivity, compared with 91.4% receiving the Comirnaty vaccine. Solicited systemic adverse events were also less frequent with VYD2311.

The company plans to combine these findings with safety and immunogenicity data from the separate DECLARATION trial for a proposed accelerated-approval application. That could advance its COVID-prevention program, but neither a filing nor approval has been completed through this announcement. LIBERTY assessed tolerability, not superior prevention of COVID infection. DECLARATION’s clinical-efficacy results remain pending, and its safety and immunogenicity topline results are expected in October.

Sources:

• Invivyd investor relations
• Nasdaq / GlobeNewswire timestamped release