Merck & Co., Inc. (MRK)'s Dust Mite Allergy Drug Reduces Symptoms In Phase 2b Study
3/5/2014 6:22:27 AM
Merck Announces Results from Phase 2b Study of MK-8237, an Investigational House Dust Mite Sublingual Allergen Immunotherapy Tablet
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada, today announced results from a Phase 2b study evaluating two doses of its investigational house dust mite sublingual immunotherapy tablet (MK-8237). The data were presented for the first time during a late-breaking oral session at the 2014 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego.
The study was conducted in 124 adult patients 18 years of age and older with house dust mite-induced allergic rhinitis, with or without conjunctivitis, using an environmental exposure chamber. In the study, MK-8237 at once-daily doses of 6 Development Units (DU) and 12 DU produced a significant dose- and time-dependent reduction in average total nasal symptom score (TNSS) over the last four hours of the chamber challenge at week 24 of treatment compared to placebo (-27%=6 DU, -49%=12 DU; p
“Merck is committed to the research and development of sublingual tablet immunotherapy options for the treatment of allergic rhinitis,” said Dr. Sean Curtis, vice president, Respiratory and Immunology, Merck Research Laboratories. “We look forward to continuing with Phase 3 research, which will provide further insight into the safety and efficacy of MK-8237.”
In this double-blind, single-site, Phase 2b study, 124 adults, 18 years of age or older, with house dust mite-induced allergic rhinitis, with or without conjunctivitis, were randomized to receive 6 DU (n=41) or 12 DU (n=42) of MK-8237 sublingual tablets once daily for 24 weeks or placebo (n=41). Sensitivity to house dust mite allergen was determined by specific IgE testing. Patients with unstable uncontrolled/partially controlled or severe asthma were excluded from the study, as were patients with forced expiratory volume in 1 second (FEV1)
Both doses of MK-8237 showed a significant dose- and time-dependent reduction in average TNSS over the last four hours of the chamber challenge at week 24 of treatment compared to placebo (-27%=6 DU, -49%=12 DU; p
In this study, the most common adverse events (incidence = 5%) occurring in patients receiving MK-8237 6 DU, 12 DU or placebo, respectively, were throat irritation (34%, 52%, 0%), mouth edema (24%, 24%, 0%), lip swelling (5%, 17%, 2%), oral pruritus (15%, 14%, 0%), dyspepsia (2%, 10%, 0%), ear pruritus (0%, 7%, 0%), swollen tongue (0%, 5%, 0%), oropharyngeal swelling (0%, 5%, 0%) and pharyngeal edema (2%, 5%, 0%). There were no local swellings of severe intensity and no serious adverse events reported in patients treated with MK-8237. The majority of adverse events in this study were assessed as mild or moderate. There were no investigator reported systemic allergic reactions or reactions treated with epinephrine for either dose of MK-8237.
A Phase 3 study of MK-8237 in adolescents and adults with house dust mite-induced allergic rhinitis is currently screening patients. Details of the study can be viewed on ClinicalTrials.gov.
Additional Merck Research Presented at AAAAI
Efficacy of the Short-Ragweed Sublingual Immunotherapy Tablet MK-3641 in Monosensitized and Polysensitized Subjects (Poster 756);
The Effect of the Ragweed Sublingual Immunotherapy Tablet MK-3641 on Rescue Medication Use (Poster 972);
The Efficacy and Safety of the Short-Ragweed Sublingual Immunotherapy Tablet MK-3641 is Similar in Asthmatic and Nonasthmatic Subjects Treated for Allergic Rhinitis with/without Conjunctivitis (AR/C) (Poster 754);
Magnitude of Changes in Patient Symptom and Medication Scores in Grass Allergy Immunotherapy Trials: Dependency on Levels of Pollen Exposure (Poster 767).
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