Merck Reports Positive Data For Grass Sublingual Allergy Immunotherapy Tablet

(RTTNews) - Drug giant Merck (MRK) Saturday announced positive data for its investigational Timothy grass sublingual allergy immunotherapy tablet (MK-7243) from a study involving 1,501 North American adult and pediatric patients.

Results from the study showed that MK-7243 showed solid 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 will present findings at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting in Baltimore.

The double-blind, randomized, placebo-controlled, parallel-group study evaluated the efficacy and safety of the MK-7243 sublingual tablet (2800 BAU) in 1,501 pediatric and adult patients with a history of Timothy grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma.

The primary efficacy assessment of the study was total combined score (TCS), which was the sum of the rhinoconjunctivitis daily symptom score (DSS) and the daily medication score (DMS) averaged over the entire grass pollen season.

The DSS consisted of daily ratings of four nasal symptoms (runny nose, blocked nose, sneezing and itchy nose) and two eye symptoms (gritty eyes and watery eyes) on a scale from zero (no symptoms) to three (severe symptoms).

The DMS was based on the type and amount of allergy rescue medication (oral antihistamines, ocular antihistamines, intranasal corticosteroids or oral corticosteroids) used each day during the grass pollen season, which patients in both arms of the study were permitted to use.

In this study, patients treated with MK-7243 showed a 23 percent improvement in TCS relative to placebo over the entire grass pollen season.

Additionally, patients treated with MK-7243 showed a 20 percent improvement in DSS over the entire grass pollen season, and a 35 percent improvement in DMS over the entire grass pollen season. During the peak grass pollen season, patients treated with MK-7243 demonstrated a 29 percent improvement in TCS, and a 12 percent improvement in RQLQ.

The most frequently reported adverse events in the study for MK-7243 were local site reactions: throat irritation, oral pruritus, oral paraesthesia, mouth edema and ear pruritus. No serious treatment-related adverse events were reported.

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 the U.S. Food and Drug Administration (FDA) had accepted for review Biologics License 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.