Merck Presents Phase III Study Results Of Investigational Oral AIT

The data was presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting in New Orleans. Merck is investigating AIT for the treatment of grass pollen allergic rhinoconjunctivitis in both children and adults.

Merck claimed that AIT is a dissolvable, investigational, oral tablet that is designed to prevent allergy symptoms by inducing a protective immune response against allergies, therefore treating the underlying cause of the disease.

AIT is currently approved in the EU for children and adults, aged between 5 and 65, with grass pollen allergy, marketed under the name Grazax by ALK-Abello, which discovered and developed the product in the EU.

Allergic rhinoconjunctivitis is caused by pollen from Timothy grass, a type of grass common in North America. A total of 345 patients, ages 5-17 years, were randomized to daily treatment with oral grass AIT (15mcg of Phl p5, which is a formulation of the timothy grass allergen) or placebo at least eight weeks prior to and throughout the 2009 grass pollen season. The primary efficacy endpoint was the total combined score, comprised of total daily symptom score and total daily medication score.

Merck also said that adverse events experienced by patients receiving AIT were generally local, application site reactions and included oral pruritus, stomatitis, throat irritation, ear pruritus, oropharyngeal pain, mouth edema, pharyngeal erythema,lip swelling and eye pruritus. The company further claimed that there were no reports of anaphylactic shock in the study. 89% of study patients were sensitive to allergens in addition to the grass pollen allergen.

James Fish, executive director of global scientific affairs at Merck Research Laboratories, said: “Merck is committed to developing respiratory products that provide physicians with a wide range of treatment options to help their patients suffering from allergies.

“We are encouraged by the positive results of this study and look forward to further developing the oral allergy immunotherapy tablet for patients suffering from allergies caused by grass pollen.”

Michael Blaiss, clinical professor of pediatrics and medicine at University of Tennessee Health Science Center in Memphis, Tennessee, and lead investigator for the study, said: “Patients who received AIT experienced significant reductions in allergy symptoms and allergy medication use, the combined symptom scores evaluated in the study. This Phase III study is the first to evaluate AIT in children and adolescents with grass pollen allergies in North America.”