Merck’s Investigational Grass Sublingual Allergy Immunotherapy Tablet Significantly Reduced Allergy Symptoms in Pivotal Phase III Study

Merck, known as MSD outside the US and Canada, has announced data for its investigational Timothy grass sublingual allergy immunotherapy tablet (MK-7243) from a study involving 1501 North American adult and pediatric patients.

Results showed that MK-7243 demonstrated significant improvement in Total Combined Score (TCS) averaged over the entire grass pollen season (the primary endpoint), which was the sum of the rhinoconjunctivitis daily symptom score (DSS) and the daily medication score (DMS), compared with placebo.

Researchers presented findings at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting, 7–11 November, in Baltimore.

“Patients in this study who took the investigational Timothy grass sublingual allergy immunotherapy tablet showed a significant improvement in common allergy symptoms during the entire grass season,” said Dr David Bernstein, professor of Medicine and Environmental Health, Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, who was one of the study investigators. “Few large studies have evaluated sublingual immunotherapy for allergic rhinitis in both adults and children, and we are proud that Merck is exploring this potential new option for Timothy grass pollen-induced allergic rhinitis treatment in North America,” said Dr Sean Curtis, Vice President, Respiratory and Immunology, Merck Research Laboratories.   

Merck's Investigational Sublingual Allergy Immunotherapy Tablet Programme

Merck's Timothy grass sublingual allergy immunotherapy tablet is an investigational once-daily tablet that dissolves under the tongue and is designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect patients against Timothy grass pollen.

Earlier this year, Merck announced that FDA had accepted for review Biologics Licence Applications for its investigational Timothy grass sublingual allergy immunotherapy tablet and its ragweed sublingual allergy immunotherapy tablet. Merck expects the FDA’s review for both to be completed in the first half of 2014.

Merck has partnered with ALK-Abello to develop its sublingual allergy immunotherapy tablets for Timothy grass pollen, ragweed pollen and house dust mite induced allergic rhinitis in North America.