Invivyd, a U.S. biopharmaceutical company, said that its investigational mRNA-based monoclonal antibody (mAB) for COVID-19 was found to be safe and tolerable in a phase 3 randomized clinical trial. CIDRAP has the news.
The trial enrolled 210 healthy adults to assess the safety and tolerability of VYD2311, which is an mAB designed for the prevention and treatment of COVID-19. Participants were randomly assigned to receive the mAB, the Pfizer/BioNTech vaccine, or both.
The endpoints monitored included the proportion of participants experiencing a treatment-emergent adverse event (TEAE), injection site reaction (ISR), hypersensitivity reaction, or systemic adverse event (AE) in the first six days following dosing. The results showed that 57% of participants who received VYD2311 experienced any TEAE, ISR, or hypersensitivity reaction, compared with 91% of those who received Comirnaty and 79% of participants who received both. Additionally, fewer patients in the VYD2311 groups experienced any TEAE, ISR, or hypersensitivity reaction over the long-term.
Data from the trial showed that combining VYD2311 with Comirnaty more than doubled the recipients' neutralizing titers. This combination suggests "potentially broader, as yet unexplored, complementarity between Invivyd monoclonal antibodies and vaccines against COVID-19 and perhaps other pathogens," Michael Mina, Invivyd's Chief Medical Officer, said in a press release.
