March 4 (Reuters) - An immunotherapy pill to treat an allergy to house dust mites being tested by Merck & Co significantly reduced common nasal symptoms, such as sneezing and stuffy nose, according to data from a midstage clinical trial, the company said on Tuesday.
The drug, MK-8237, reduced nasal symptoms by 49 percent at the higher tested dose and 27 percent at the lower dose compared with a placebo after 24 weeks of treatment. The results, which were deemed to be statistically significant, were presented on Tuesday at the American Academy of Allergy, Asthma and Immunology (AAAAI) meeting in San Diego.
MK-8237, a once-a-day tablet designed to dissolve under the tongue, is the third oral allergy immunotherapy treatment being developed by Merck.
The U.S. drugmaker and its Danish allergy development partner ALK Abello are awaiting U.S. approval decisions likely this year for sublingual tablets that treat grass and ragweed allergies that would be alternatives to regular allergy shots at a doctor’s office.
Over time, the drugs train the immune system to stop reacting abnormally to exposure to allergens.
The primary goal of the 124-patient study was a significant reduction at week 24 in average total nasal symptom score (TNSS) reported over the last four hours of a six-hour session in a special room where they were exposed to enough dust mites to set off allergic reactions. TNSS was comprised of itchy nose, blocked nose, runny nose and sneezing.
A secondary goal combined TNSS results at 24 weeks with a measure of ocular symptoms, such as red, itchy or watery eyes. By that measure, the higher dose of the Merck drug reduced symptoms by 52 percent compared with placebo and by 29 percent for the lower dose. The reduction in eye symptoms alone was as high as 68 percent, Merck said.
“We had not expected to see such pronounced effects on both nasal and ocular symptoms with this product, so we are very encouraged by this data,” Dr. Hendrik Nolte, clinical leader of Merck’s allergy immunotherapy program who presented the data at the meeting, said in a telephone interview.
No serious adverse side effects were reported by patients in the study. The most common side effects, deemed to be mild to moderate, included throat irritation, mouth edema and lip swelling.
Merck said it is recruiting patients for a large, pivotal Phase III trial of the dust mite allergy treatment that it hopes to complete next year.