Invivyd reports Phase 3 VYD2311 COVID-19 trial results

• Invivyd reported Phase 3 LIBERTY trial results showing fewer adverse events with VYD2311 compared with an mRNA COVID-19 vaccine.
• VYD2311 met six-day co-primary safety endpoints and a 56-day secondary safety endpoint in the study.
• The company plans to pursue accelerated approval if additional DECLARATION trial results are supportive.

Invivyd (NASDAQ:IVVD) reported Phase 3 LIBERTY trial results showing that its investigational COVID-19 antibody product VYD2311 demonstrated fewer reported adverse events compared with an mRNA COVID-19 vaccine.

The LIBERTY trial enrolled 210 adults and evaluated safety outcomes following treatment. Invivyd said VYD2311 met both six-day co-primary safety endpoints and the 56-day secondary endpoint.

At six days after dosing, adverse events occurring after treatment, injection-site reactions, or hypersensitivity events were reported in 56.5% of VYD2311 recipients compared with 91.4% of vaccine recipients.

Systemic adverse events occurred in 44.1% of VYD2311 recipients versus 68.1% of vaccine recipients.

At 56 days, the rate for the combined measure of post-dose adverse events, injection-site reactions, or hypersensitivity events was 60.9% for VYD2311 recipients compared with 91.4% for vaccine recipients.

Invivyd also reported that adding VYD2311 to the vaccine increased neutralizing antibody titers by approximately 2.5 times over 56 days, without observed interference with vaccine-induced immune responses.

The company said it plans to seek accelerated approval using LIBERTY and DECLARATION trial data if results from DECLARATION are supportive.

Safety and immune-response results from DECLARATION are expected in October, while clinical efficacy data would be unblinded after accelerated approval, if granted, and subject to sufficient clinical events occurring.