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RAHWAY, N.J. - Merck (NYSE: MRK), a pharmaceutical giant with a market capitalization of over $200 billion and an impressive 77% gross profit margin, announced Thursday the initiation of MOBILIZE-1, the first Phase 3 clinical trial evaluating V181, an investigational single-dose quadrivalent vaccine for dengue disease prevention. According to InvestingPro analysis, Merck maintains a "GREAT" financial health score, positioning it strongly for continued R&D investments.
The study aims to enroll approximately 12,000 healthy participants aged 2 to 17 years across more than 30 trial sites in dengue-endemic areas of the Asia-Pacific region, including Indonesia, Malaysia, Philippines, Singapore, Thailand and Vietnam. Recruitment has begun with the first participants enrolling in Singapore. As a prominent player in the pharmaceuticals industry with annual revenue exceeding $63 billion, Merck has the resources to conduct large-scale clinical trials globally.
V181 is designed to prevent dengue disease caused by any of the four dengue virus serotypes, regardless of previous exposure to the virus. The randomized, double-blind, placebo-controlled study will evaluate the vaccine’s safety, immunogenicity and efficacy.
"Approximately half of the world’s population live in areas with a risk for dengue, making it a serious public health threat," said Dr. Paula Annunziato, senior vice president at Merck Research Laboratories, according to the press release.
Dengue disease affects approximately 105 million people annually, with 50-60 million experiencing symptoms. About 4-11 million cases result in hospitalizations each year, with an average of 29,000 dengue-related deaths worldwide annually.
The primary endpoints of the MOBILIZE-1 study include safety and efficacy in preventing symptomatic virologically confirmed dengue of any severity due to any of the four dengue serotypes. Secondary endpoints include prevention of symptomatic dengue with warning signs, severe dengue, and hospitalization.
The trial represents the first Phase 3 study in Merck’s planned clinical development program for the vaccine candidate. For investors interested in deeper analysis, InvestingPro indicates that Merck is currently undervalued and offers additional insights through its comprehensive Pro Research Report, available as part of the subscription covering 1,400+ top US stocks.
In other recent news, Merck & Co. Inc. announced the U.S. Food and Drug Administration’s approval of its RSV prevention drug, ENFLONSIA, for infants. This drug is expected to provide protection during the RSV season, with its approval supported by significant trial results showing reductions in RSV-associated infections. Additionally, Merck reported positive Phase 3 trial outcomes for enlicitide, an investigational oral cholesterol-lowering medication, indicating significant reductions in LDL-C levels. The trials showed enlicitide’s potential as the first oral PCSK9 inhibitor, pending regulatory approval. In other developments, Cantor Fitzgerald maintained a Neutral rating on Merck, citing ongoing concerns about the Gardasil vaccine’s dosage recommendations and potential sales impact. Meanwhile, the approval of Merck’s RSV vaccine Enflonsia has introduced competition in the market, affecting Swedish Orphan Biovitrum’s Beyfortus. The implications of these developments are being closely watched by investors, especially with the upcoming Advisory Committee on Immunization Practices meeting that may influence market strategies for both Gardasil and Enflonsia.
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