Drugmaker Merck & Co. Inc. (MRK) said Monday that results from a late-stage trial of its investigational allergy immunotherapy tablet for ragweed pollen showed that the use of the tablet "significantly reduced" the combination of ragweed allergy symptoms and rescue medication use in adults with ragweed-induced allergy, with or without asthma.
The company also said it plans to file new drug applications for ragweed and grass allergy tablets in 2013.
Merck's allergy immunotherapy tablet or AIT is an investigational, dissolvable oral tablet designed to treat the underlying cause of allergies. The drug is being studied to determine whether it may help to prevent allergy symptoms by generating an immune response to protect against targeted allergens.
The multicenter Phase III trial was designed to assess the efficacy and safety of two doses of ragweed AIT. The study involved 565 adults in the age group of 18 to 50 with ragweed-induced allergic rhinoconjunctivitis, with or without asthma. The study was conducted during peak ragweed pollen season.
Patients were randomized to receive a once-daily tablet of Ambrosia artemisiifolia, or ragweed allergen extract, for about 16 weeks prior to and throughout the ragweed pollen season, for a total treatment period of 52 weeks.
According to Merck, the study results showed that the use of ragweed AIT significantly reduced the total combined score that measured nasal and eye symptoms as well as reduced the use of rescue allergy medicines, compared to placebo, in ragweed-allergic adults with or without asthma.
Merck noted that during peak ragweed season, patients taking the company's pill experienced 27 percent and 21 percent reductions in the total combined score, respectively, at the higher and lower doses, compared with patients taking placebos.
During the peak ragweed season, the pill reduced allergy symptoms by 17 percent at higher doses and 14 percent at the lower doses. The pill also reduced the need for standard rescue medications by 45 percent and 34 percent, respectively, at the two doses. The peak ragweed pollen season is a time when rescue medications are expected to be utilized the most.
The data from the study were presented at the American Academy of Allergy, Asthma & Immunology or AAAAI annual meeting in Orlando.
Rupert Vessey, senior vice president and franchise head of Respiratory & Immunology, Merck Research Laboratories said, "Merck is pleased that patients who took its AIT in this study experienced a significant reduction in the nasal and eye symptoms caused by ragweed allergies, and these positive results are an important step in the development of this investigational therapy."
Merck is investigating disease-modifying AITs for the treatment of allergies caused by ragweed pollen, grass pollen and house dust mites. The company has partnered with Danish pharmaceutical company ALK-Abello A/S to develop drugs to treat these allergens in North America.
In Monday's regular session, MRK is trading at $38.19, up $0.26 or 0.69 percent on a volume of 149,485 shares.
by RTT Staff Writer
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