Merck & Co. Inc. announced positive second-season findings from the Phase 3 SMART trial (MK-1654-007; NCT04938830) evaluating ENFLONSIA (clesrovimab) in infants and children under 2 years of age at increased risk for severe respiratory syncytial virus (RSV) disease over two RSV seasons. The company said safety in season 2 was generally consistent with season 1, and serum concentrations in high-risk children under 2 were similar to those observed in healthy infants in the Phase 2b/3 CLEVER trial (MK-1654-004; NCT04767373), supporting extrapolation of efficacy to a second RSV season in this population. The second-season results were presented in an oral session at the 9th RSVVW Conference (ReSViNET), and Merck said the data will be shared with the U.S. FDA and other regulatory authorities to support evaluation of an expanded indication.

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