Merck Announces Topline Results from Phase 2b/3 Trial of Clesrovimab (MK-1654), an Investigational Respiratory Syncytial Virus Preventative Monoclonal Antibody for Infants
Merck (NYSE: MRK) has announced positive topline results from its Phase 2b/3 clinical trial of clesrovimab (MK-1654), an investigational monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease. The trial met all primary safety and efficacy endpoints, including reducing medically attended lower respiratory infections (MALRI) caused by RSV through Day 150.
Merck plans to present detailed findings at an upcoming scientific congress and file the data with global regulatory authorities. Dr. Paula Annunziato, senior vice president at Merck Research Laboratories, emphasized the significance of these results, noting that RSV is the leading cause of hospitalization for healthy infants globally.
Merck (NYSE: MRK) ha annunciato risultati positivi preliminari dal suo trial clinico di fase 2b/3 di clesrovimab (MK-1654), un anticorpo monoclonale in fase di sperimentazione progettato per proteggere i neonati dalle infezioni da virus respiratorio sinciziale (RSV). Lo studio ha raggiunto tutti gli obiettivi primari di sicurezza ed efficacia, incluso il ridurre le infezioni respiratorie inferiori di origine medica (MALRI) causate dal RSV fino al Giorno 150.
Merck prevede di presentare i risultati dettagliati in un prossimo congresso scientifico e di inviare i dati alle autorità regolatorie globali. La Dott.ssa Paula Annunziato, vicepresidente senior presso i Merck Research Laboratories, ha sottolineato l'importanza di questi risultati, evidenziando che il RSV è la principale causa di ospedalizzazione per i neonati sani a livello globale.
Merck (NYSE: MRK) ha anunciado resultados preliminares positivos de su ensayo clínico de fase 2b/3 sobre clesrovimab (MK-1654), un anticuerpo monoclonal en investigación diseñado para proteger a los recién nacidos de la enfermedad causada por el virus sincitial respiratorio (RSV). El ensayo cumplió con todos los objetivos primarios de seguridad y eficacia, incluyendo la reducción de infecciones respiratorias inferiores atendidas médicamente (MALRI) causadas por RSV hasta el día 150.
Merck planea presentar los hallazgos detallados en un próximo congreso científico y presentar los datos a las autoridades regulatorias globales. La Dra. Paula Annunziato, vicepresidenta sénior de Merck Research Laboratories, enfatizó la importancia de estos resultados, señalando que el RSV es la principal causa de hospitalización para recién nacidos sanos a nivel mundial.
머크(Merck, NYSE: MRK)는 클레스로비맙(MK-1654)의 2b/3상 임상시험에서 긍정적인 최종 결과를 발표했습니다. 클레스로비맙은 신생아를 호흡기 세포융합 바이러스(RSV) 질병으로부터 보호하기 위해 설계된 연구용 단일클론 항체입니다. 이 시험은 150일 동안 RSV로 인한 의료 개입 하에 발생한 하부 호흡기 감염(MALRI) 감소를 포함하여 모든 주요 안전성과 효능 목표를 충족했습니다.
머크는 다가오는 과학 컨퍼런스에서 상세한 결과를 발표하고 이 데이터를 글로벌 규제 당국에 제출할 계획입니다. 머크 연구소의 수석 부사장인 파울라 안눈치아토 박사는 이러한 결과의 중요성을 강조하며, RSV가 전 세계적으로 건강한 신생아 입원의 주요 원인이라고 언급했습니다.
Merck (NYSE: MRK) a annoncé des résultats préliminaires positifs de son essai clinique de phase 2b/3 sur clesrovimab (MK-1654), un anticorps monoclonal investigational destiné à protéger les nourrissons contre la maladie du virus respiratoire syncytial (RSV). L'essai a atteint tous les principaux objectifs de sécurité et d'efficacité, y compris la réduction des infections respiratoires inférieures nécessitant une attention médicale (MALRI) causées par le RSV jusqu'au jour 150.
Merck prévoit de présenter des résultats détaillés lors d'un prochain congrès scientifique et de soumettre les données aux autorités réglementaires mondiales. Dr. Paula Annunziato, vice-présidente senior des Merck Research Laboratories, a souligné l'importance de ces résultats, notant que le RSV est la principale cause d'hospitalisation des nourrissons en bonne santé dans le monde.
Merck (NYSE: MRK) hat positive vorläufige Ergebnisse aus seiner klinischen Phase 2b/3-Studie zu clesrovimab (MK-1654) bekannt gegeben, einem experimentellen monoklonalen Antikörper, der entwickelt wurde, um Säuglinge vor Erkrankungen durch das respiratorische Synzytialvirus (RSV) zu schützen. Die Studie erreichte alle primären Sicherheits- und Wirksamkeitsziele, einschließlich der Verringerung von medizinisch betreuten unteren Atemwegsinfektionen (MALRI), die durch RSV bis zum 150. Tag verursacht werden.
Merck plant, die detaillierten Ergebnisse auf einem bevorstehenden wissenschaftlichen Kongress zu präsentieren und die Daten bei den globalen Regulierungsbehörden einzureichen. Dr. Paula Annunziato, Senior Vice President bei Merck Research Laboratories, betonte die Bedeutung dieser Ergebnisse und stellte fest, dass RSV die hauptursächliche Krankheit für Krankenhausaufenthalte bei gesunden Säuglingen weltweit ist.
- Clesrovimab met all primary safety and efficacy endpoints in the Phase 2b/3 trial
- The drug reduced medically attended lower respiratory infections caused by RSV through Day 150
- Merck plans to file the data with global regulatory authorities
- None.
Insights
Dr. Emily Rosen, Medical Research Analyst
The positive results from the Phase 2b/3 trial of clesrovimab (MK-1654) are highly promising. Considering RSV's status as a leading cause of hospitalization in infants, a successful prophylactic treatment could significantly reduce healthcare burdens. The trial met its primary safety and efficacy endpoints, signaling a robust potential for the drug to prevent medically attended lower respiratory infections (MALRI) caused by RSV. This could translate to fewer hospital visits and lower healthcare costs, benefiting both patients and the medical system. Additionally, monoclonal antibodies like clesrovimab are specifically designed to target and neutralize pathogens, offering a targeted approach with potentially fewer side effects compared to broader antiviral drugs.
Michael Grant, Financial Analyst
From a financial perspective, Merck's announcement could be a game-changer. Successfully hitting all primary safety and efficacy endpoints in a Phase 2b/3 trial is a significant milestone. This improves the likelihood of regulatory approval and subsequent market entry, which could potentially open new revenue streams for the company. Given that RSV is a major cause of infant hospitalization, especially in colder months, a seasonal prophylactic treatment like clesrovimab could see high demand. This would positively impact Merck's financial performance, potentially boosting their stock price as investors anticipate future earnings growth.
Sarah Thompson, Market Research Analyst
Analyzing the market implications, the successful development of clesrovimab can position Merck strongly in the pediatric healthcare segment. RSV prophylactics currently have limited options and a new effective treatment could capture significant market share. Moreover, this aligns well with Merck's strategic focus on expanding its vaccine and infectious disease portfolio. Given the global burden of RSV, the drug’s approval would not only benefit infants in the U.S. and Canada but also internationally, broadening Merck's global market reach. Additionally, the ability to present these data at an upcoming scientific congress will further validate Merck's leadership in infectious disease research, fostering trust and credibility within the medical community.
Clesrovimab met all primary safety and efficacy endpoints
“RSV is highly contagious and can cause inflammation in the airways of infants leading to difficulty breathing. As a widespread illness globally, RSV is the leading cause of hospitalization for healthy infants,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories. “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."
About MK-1654-004
MK-1654-004 (NCT04767373) is a Phase 2b/3 double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of clesrovimab in healthy preterm and full-term infants. Participants were randomized to receive either a single dose of clesrovimab or placebo. The primary endpoints include the incidence of participants with RSV-associated medically attended lower respiratory infection (MALRI) from Day 1 (post dose) to Day 150 as compared to placebo and safety. Safety measures assessed included the percentage of participants with any injection-related adverse events (AEs), AEs of special interest (AESIs) solicited systemic AEs, or serious adverse events (SAEs).
About Clesrovimab (MK-1654)
Clesrovimab (MK-1654) is an investigational extended half-life monoclonal antibody (mAb) developed as a passive immunization for the prevention of RSV-associated medically attended lower respiratory infection (MALRI). Clesrovimab is being studied in infants (pre-term and full-term) to provide rapid, durable protection through their first RSV season with a single, fixed-dose administration.
About RSV
Respiratory syncytial virus (RSV) is a contagious virus that causes widespread seasonal infection with a worldwide burden in infants and older adults. There is high unmet need for preventative options in both healthy and high-risk infants. Globally, it is the leading cause of hospitalization for healthy infants under a year old. RSV can lead to serious respiratory conditions like bronchiolitis and pneumonia, causing an estimated 101,000 deaths a year worldwide in children under five.
About Merck
At Merck, known as MSD outside of
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