Merck’s Clesrovimab Shows Promise in Protecting Infants from RSV: Phase 2b/3 and Interim Phase 3 Trial Results
Merck & Co. Inc. (MRK) has announced encouraging results from its ongoing research into a potential treatment for respiratory syncytial virus (RSV) in infants. The company’s investigational monoclonal antibody, clesrovimab, has shown significant promise in protecting infants from the potentially severe consequences of RSV infection.
Results from a Phase 2b/3 pivotal trial (MK-1654-004) evaluating a single dose of clesrovimab administered to healthy preterm and full-term infants (birth to 1 year of age) met all prespecified endpoints. The trial demonstrated that clesrovimab effectively reduced the incidence of RSV-associated medically attended lower respiratory infections (MALRI) requiring hospitalization.
Key Highlights from the Phase 2b/3 Trial:
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Reduced RSV-Associated Infections:
Clesrovimab significantly reduced the incidence of RSV-associated MALRI by 60.4% compared to placebo.*
Decreased Hospitalizations:
The treatment also led to an 84.2% reduction in RSV-associated hospitalizations and a 90.9% decrease in RSV-associated LRI hospitalizations.*
Mitigated Severe Infections:
Clesrovimab reduced the incidence of severe MALRI by 91.7%.*
Favorable Safety Profile:
The incidence of adverse events (AEs) and serious AEs was comparable between the clesrovimab and placebo groups, and there were no treatment or RSV-related deaths during the study.Interim Phase 3 Trial Results:
Merck also presented interim findings from its ongoing Phase 3 trial (MK-1654-007) evaluating the safety and efficacy of clesrovimab compared to palivizumab (Synagis), another monoclonal antibody used to prevent severe RSV disease in high-risk infants.
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Comparable Safety Profile:
The interim results demonstrated that clesrovimab had a comparable safety profile to palivizumab, with no drug-related serious AEs reported.*
Similar Efficacy:
The incidence rates of RSV-associated MALRI and RSV-associated hospitalizations were also comparable between the two treatment groups.Potential Impact:
These positive results suggest that clesrovimab has the potential to become a valuable tool in preventing severe RSV disease in infants. RSV is a common respiratory virus that can cause serious illness, particularly in infants and young children.
Looking Ahead:
Merck plans to continue its research and development efforts for clesrovimab. If the ongoing Phase 3 trial successfully demonstrates the safety and efficacy of clesrovimab, the company plans to seek regulatory approval for the treatment. The potential availability of clesrovimab could significantly impact the prevention and management of RSV disease in infants and contribute to improved health outcomes.