Invivyd announced positive Phase 1/2 clinical trial data for VYD2311, a monoclonal antibody designed to offer superior, long-lasting protection against COVID-19 compared to existing vaccines. The trial, involving 40 subjects, evaluated intravenous, intramuscular, and subcutaneous administration, demonstrating positive safety and pharmacokinetic results, supported by strong antiviral activity. VYD2311 offers a potential alternative to frequent booster shots and addresses limitations of current therapies.

This development is crucial given the continuing impact of COVID-19, including deaths, hospitalizations, and the rise of Long COVID, despite widespread vaccination and treatment efforts. VYD2311 could significantly reduce the disease burden and offer a more convenient and effective approach to managing COVID-19. It holds particular promise for immunocompromised individuals and others who struggle to mount an adequate immune response to vaccines.

Data from the trial reveal mild to moderate adverse events primarily related to injection site or infusion reactions. As of day 65, serum concentrations of VYD2311 remained high, suggesting a long half-life and potentially infrequent dosing intervals (e.g., annually or biannually). In vitro data show VYD2311 possesses approximately 17-fold greater neutralization potency than pemivibart, a current Invivyd mAb for COVID-19. This increased potency could translate to lower doses or enhanced antiviral activity. Preliminary data suggest VYD2311’s pharmacokinetic profile is similar to adintrevimab, a prior Invivyd mAb with an estimated half-life of 139 days.

This positive data positions VYD2311 as a potential game-changer in the fight against COVID-19. The potential for long-lasting protection with less frequent dosing, combined with a favorable safety profile and enhanced potency, could revolutionize preventative strategies and treatment options. Further research and development will focus on confirming these promising results and potentially establishing VYD2311 as a first-line defense against COVID-19 for a broader population.

Source link: https://www.globenewswire.com/news-release/2025/02/03/3019374/0/en/Invivyd-Announces-Positive-Phase-1-2-Clinical-Data-for-VYD2311-a-Monoclonal-Antibody-Designed-to-be-a-Superior-Alternative-to-COVID-19-Vaccination-for-the-Broad-Population.html

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.