The investigational monoclonal antibody MK-1654 (clesrovimab) designed for the prevention of respiratory syncytial virus (RSV) in infants has shown positive topline results during a phase 2b/3 clinical trial, Merck announced in a release.1
Results from the phase 2b/3 trial showed that the therapy met its primary efficacy endpoint of incidence of patients with RSV-associated medically attended lower respiratory infections (MALRI) through Day 150. MK-1654 also met its primary safety endpoints, including percentage of participants with any injection-related adverse events, adverse events of special interest, solicited systemic adverse events, or serious adverse events.
About MK-1654-004
Trial Name: Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
ClinicalTrials.gov Identifier: NCT04767373
Sponsor: Merck Sharp & Dohme LLC
Summary: The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.
“RSV is highly contagious and can cause inflammation in the airways of infants leading to difficulty breathing,” Paula Annunziato, senior vice president of infectious diseases and vaccines Global Clinical Development at Merck Research Laboratories, said in a release.1 “As a widespread illness globally, RSV is the leading cause of hospitalization for healthy infants.”
READ MORE: HHS Awards Moderna $176 Million to Develop Pandemic-Ready Influenza Vaccine
MK-1654-004 (NCT04767373) is a double-blind, randomized, placebo-controlled phase 2b/3 study evaluating the safety and efficacy of MK-1654 in healthy preterm and full-term infants. The study cohort included 3632 patients 1 year of age or younger who randomly received either a single dose of the monoclonal antibody or placebo.
MK-1654 is an investigational extended half-life monoclonal antibody that was developed to provide durable protection against RSV with a single, fixed-dose administration. The passive immunization is being studied for the prevention of RSV-associated MALRI.
Merck said in the news release that more detailed findings from the study will be presented at an upcoming scientific meeting. The company also said that it intends to file the trial data with global regulatory authorities.
“We are encouraged by these findings and look forward to working with regulators to provide a new option to help address the impact of RSV on infants and their families," Annunziato said in a release.1
RSV is the leading cause of hospitalization in the first year of life in the United States, accounting for 57000 hospitalizations in children younger than 5 years of age.2 Among children who are hospitalized for RSV, 1 in 5 are admitted to the intensive care unit. Although most children infected with RSV have mild, cold-like symptoms, others can experience more severe disease, including bronchiolitis and pneumonia.3
There are currently 3 therapies for the prevention of RSV in infants and young children that are recommended by the CDC. These include the maternal RSV vaccine Abrysvo from Pfizer, as well as the monoclonal antibody nirsevimab. Another monoclonal antibody, palivizumab, is limited to children 24 months of age and younger with certain conditions that place them at high risk for severe disease.4
READ MORE: Immunization Resource Center
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References
2. Halasa N, Zambrano LD, Amarin JZ, et al. Infants Admitted to US Intensive Care Units for RSV Infection During the 2022 Seasonal Peak. JAMA Netw Open. 2023;6(8):e2328950. doi:10.1001/jamanetworkopen.2023.28950
4. Respiratory Syncytial Virus (RSV) Immunizations. Report. CDC. July 3, 2024. Accessed July 23, 2024. https://www.cdc.gov/vaccines/vpd/rsv/index.html
