Merck (NYSE: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>
"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."
Study Design
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>1) <70 percent of predicted value. Participants were exposed to the house dust mite allergen using an environmental exposure chamber at weeks 8, 16 and 24. This method allows for controlled and reproducible conditions that provide a constant concentration of allergen over a six-hour period with patients recording symptoms every 15 minutes.
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