Merck/ALK-Abello plan 2013 US filings for ragweed and grass allergy immunotherapy
This article was originally published in Scrip
Merck & Co and its partner ALK-Abello plan to file for US approval of their investigational ragweed and grass allergy immunotherapy (AIT) tablets next year, following the announcement of positive Phase III results for the ragweed pollen AIT at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Orlando, Florida.
The data showed that ragweed allergy immunotherapy significantly reduced the total combined score measuring nasal and eye symptoms and use of rescue allergy medicines, compared with placebo, in ragweed-allergic adults with or without asthma. The study was conducted during peak ragweed pollen season, Merck noted.
AIT is a dissolvable oral tablet designed to treat the underlying cause of allergies, and is also being studied to see whether it can prevent allergy symptoms developing by generating an immune response against targeted allergens. The company is investigating disease-modifying allergy immunotherapy tablets for the treatment of allergies caused by other allergens including house dust mites (in Phase II development).
Merck has partnered with ALK-Abello to develop allergy immunotherapy tablets in the US, Canada and Mexico, and submitted an application to Health Canada for a grass product last year. "We view daily sublingual allergy immunotherapy tablets as an alternative to shots for those sufferers who opt not to receive shots," Merck told Scrip.
It added that there are roughly 30 million moderate to severe allergy sufferers each year in the US. Currently, approximately three million sufferers receive immunotherapy shots of which half drop-off within 12 months of therapy initiation.
study details
The multicentre, double-blind, placebo-controlled, parallel-group Phase III trial was designed to assess the efficacy and safety of two doses of ragweed allergy immunotherapy in 565 adults aged between 18 to 50 years old who had ragweed-induced allergic rhinoconjunctivitis, with or without asthma. Of these patients, 85% were sensitive to multiple allergens.
Patients were randomised to receive a once-daily tablet of Ambrosia artemisiifolia (ragweed) allergen extract at high or low doses, or placebo, for approximately 16 weeks before and throughout the ragweed pollen season, for a total treatment period of 52 weeks. They recorded their symptoms and rescue medication use daily in electronic diaries during ragweed pollen season.
The primary efficacy assessment was total combined score, of the daily symptom score and the daily medication score averaged over the peak ragweed pollen season. The daily symptom score consisted of daily ratings of four nasal symptoms (runny nose, blocked nose, sneezing, and itchy nose) and two eye symptoms (gritty eyes and watery eyes) on a scale from zero to three, and the daily medication score was based upon the type and amount of rescue medication used each day.
During peak ragweed season, patients treated with ragweed AIT showed 27% (high dose) and 21% (low dose) reductions in total combined score, respectively, relative to placebo (p=0.0002 and p=0.0039).
Specifically, both doses of ragweed AIT resulted in significant reductions in daily symptom score relative to placebo during peak ragweed season (17% for high dose, p=.0144; and 14% for low dose, p=.0472). Ragweed AIT yielded 45% (high dose) and 34% (low dose) reductions in daily medication score, respectively, relative to placebo (p=0.0001 and p=0.0039) during peak ragweed pollen season, a time when rescue medications are expected to be used most.
The most frequently reported treatment-related adverse events were itchiness of the mouth and ear and throat irritation. Two patients received epinephrine during the course of the study. There were no reports of death, systemic allergic reactions or life-threatening events over 52 weeks.