Invivyd, an American biopharma company, have announced positive Phase I/II clinical results for their non-vaccine preventative therapy for COVID-19. The drug, called VYD2311, is a mAb targeting the SARS-CoV-2 virus for both prophylaxis and treatment of COVID-19.
The Phase I/II clinical trial evaluated the safety and pharmacokinetic profile of VYD2311 in 40 patients across four cohorts with varying route of administration. Patients were dosed with the treatment or placebo either intravenously, intramuscularly, or subcutaneously to ensure the flexibility of pathways available for the drug.
“These data reinforce our confidence in VYD2311’s potential to offer a highly effective, scalable, convenient, and accessible solution for COVID-19 prevention,” said Mark Wingertzahn, SVP of Clinical Development at Invivyd.
Results from the trial show that the antibody was well tolerated with only mild to moderate adverse events.
The drug is the next generation of Invivyd’s previous COVID antibody, pemivibart, intended to increase its half-life to lengthen the protection from infection. Results indicated that VYD2311 met its pharmacokinetic endpoint with an in vivo half-life 61 days when dosed IV and 76 days IM, significantly longer than the 49 day half-life of pemivibart.
Wingertzahn commented: “The safety profile, long half-life, and novel dosing strategies explored with VYD2311 not only build upon the well-established science for COVID-19 mAbs to achieve robust modelled efficacy targets but also align with our mission to provide non-vaccine mediated protection to those most at risk, including immunocompromised individuals, in a manner that integrates seamlessly into standard healthcare settings.”