Safety, tolerability, and pharmacokinetics of the respiratory syncytial virus-prefusion F-targeting monoclonal antibody with an extended half-life, MEDI8897, in healthy adults [PublishAheadOfPrint]

Prevention of respiratory syncytial virus (RSV) illness in infants is a major public health priority, but there is no approved vaccine. Palivizumab is a monoclonal antibody that provides RSV prophylaxis but requires 5 monthly injections and is approved only for infants who experience the greatest morbidity and mortality from RSV. Thus, there remains a significant unmet medical need for prevention of RSV disease in healthy infants. MEDI8897 is a recombinant human RSV monoclonal antibody with a modified Fc region that extends its half-life and is being developed as RSV prophylaxis for all infants. In this phase 1, first-in-human, placebo-controlled study, 136 healthy adults were randomized to receive a single dose of MEDI8897 (n = 102) or placebo (n = 34) in 1 of 5 cohorts (300, 1000, or 3000 mg intravenous or 100 or 300 mg intramuscular [IM]) and were followed for 360 days. The mean half-life of MEDI8897 was 85 to 117 days across dose groups, and bioavailability after 300-mg IM dose administration was 77%. Time to maximum concentration following IM dosing was 5 to 9 days. Antidrug antibody (ADA) responses were detected in a similar proportion of placebo (15.2%) and MEDI8897 (13.7%) recipients. The safety profile of MEDI8897 was similar to placebo. These results support clinical studies of the IM administration of a single dose of MEDI8897 in the target population of infants to provide protection for the duration of the RSV season.

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