An antibody therapy for COVID19 both prevents and treats SARSCoV2 infections—including with some variants of concern—in large animals, and shows promising activity and extended half-life in human volunteers. ScienceTM
). Accelerated viral clearance and reduced immunopathology in NHPs also supported the study of AZD7442 as treatment for COVID-19 to prevent disease progression.
Prophylactic and therapeutic efficacy of AZD7442 was assessed in SARS-CoV-2 challenge studies in NHPs . These studies were approved by the IACUC and conducted at BIOQUAL, Inc., in adherence of the following standards of the Association for Assessment and Accreditation of Laboratory Animal Care: the 82015 reprint of the Public Health Service Policy on Human Care and Use of Laboratory Animals
Clinical results are reported from an ongoing phase 1, randomized, double-blind placebo-controlled, dose-escalation study of the safety, tolerability, and pharmacokinetics of AZD7442 in healthy adult participants with no prior history of COVID-19 and no prior receipt of a COVID-19 vaccine . Participants, investigators, clinical staff, and the study monitor were all blinded from the assigned intervention.
For the first NHP SARS-CoV-2 challenge study, 14 rhesus macaques of Indian origin, aged 5 to 6 years and weighing between 3.6 and 7.3 kg, received prophylactic 10 ml IV infusions of the following mAbs 3 days prior to SARS-CoV-2 challenge: 40 mg/kg isotype control mAb R347-TM-YTE ; 40 mg/kg AZD7442 ; 4 mg/kg AZD7442 ; or 4 mg/kg AZD7442-YTE . Four additional rhesus macaques weighing between 4.6 and 6.
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