Merck & Co (MSD) has reported new data from its Phase III SMART trial evaluating Enflonsia (clesrovimab) in infants and children under two years at increased risk for severe respiratory syncytial virus (RSV) disease.
Presented at the Respiratory Syncytial Virus Foundation conference in Rome, Italy, the findings focus on participants spanning two RSV seasons.
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The partially-blind, randomised, multi-centre, palivizumab-controlled trial assessed Enflonsia’ the’s efficacy, pharmacokinetics and safety.
It enrolled early (less than 29 weeks gestational age) or moderate preterm infants (29 to 35 weeks gestational age), as well as infants with chronic lung disease (CLD) of prematurity or congenital heart disease (CHD).
In the first RSV season, subjects were assigned into 1:1 ratio to receive either a 105mg Enflonsia dose or monthly palivizumab administered via intramuscular injection.
In the second season, eligible children under two years with CLD, CHD or preterm birth with risk conditions received an open-label 210mg dose of the therapy as two 105mg injections. Among the 276 children treated in the second season, almost all had CLD or CHD.
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By GlobalDataThe results indicate that safety in children under two years who received Enflonsia at the start of their second RSV season was generally consistent with that observed during the first season.
MSD Research Laboratories vice-president and global clinical development therapeutic area head Dr Macaya Douoguih said: “These new data from the SMART study further position Enflonsia as an important potential new option to help protect young children who remain at high risk entering their second RSV season.
“We aspire to bring Enflonsia to all eligible infants and high-risk children under two years of age around the world and look forward to sharing these encouraging data with global regulatory authorities to help achieve this goal.”
The latest results will be submitted to regulatory authorities, including the FDA, for evaluation towards an expanded indication. Enflonsia presently holds approval in Canada, the US and several other countries for use in infants during their first RSV season, with further regulatory filings ongoing.
Earlier this year, MSD commenced the KANDLELIT-007 Phase III trial to assess calderasib (MK-1084), with Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) in patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).
