Merck Reports Results From MK-8237 Phase 2B Study
Merck presented new data from a Phase 2B study assessing two doses of MK-8237, its investigational house dust mite sublingual immunotherapy tablet. The company presented the data for the first time at the 2014 Annual Meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI) in San Diego.
124 adults 18 years of age and older with house dust mite-induced allergic rhinitis, with or without conjunctivitis, were involved in the study which used an environmental exposure chamber. The double-blind, single-site, Phase 2B study randomized the patients to receive 6 Development Units (DU) or 12 DU of MK-8237 sublingual tablets once daily or placebo for 24 weeks. Patient sensitivity to house dust mite allergen was measured by specific lgE testing. Patients were exposed to the allergen using an environmental exposure chamber at weeks 8, 16, and 24. The method allowed for controlled and reproducible conditions that provided a constant allergen concentration over a six hour period with patients recording their symptoms every 15 minutes. Those with unstable uncontrolled/partially controlled or severe asthma were excluded from the study.
Both 6 DU and 12 DU doses of MK-8237 showed significant dose- and time-dependent reduction in average total nasal symptom score (TNSS) over the last four hours of the chamber observation period at week 24 of treatment. TNSS measures nasal symptoms itchy nose, runny nose, blocked nose, and sneezing. The investigational drug also showed dose-dependent reductions against placebo in average total symptom score (TSS) at week 24.
Dr. Sean Curtis, Vice President of Respiratory and Immunology at Merck Research Laboratories, said, “Merck is committed to the research and development of sublingual tablet immunotherapy options for the treatment of allergic rhinitis. We look forward to continuing with Phase 3 research, which will provide further insight into the safety and efficacy of MK-8237.” Patient screening is presently ongoing for a Phase III study for MK-8237 in adolescents and adults with house dust mite-induced allergic rhinitis.