ALK-Abelló, devoted to improving the lives of people with allergies by developing pharmaceutical products that target the cause of allergy, presented successful phase III clinical study results with Grazax in children at the American Academy of Allergy, Asthma and Immunology (AAAAI 2008) in Philadelphia.
More than 250 patients participated in the randomized, double blind, placebo controlled trial. In the grass pollen season (using a threshold of 30 grains/m3), Grazax reduced hay fever symptoms by 28 per cent and reduced the need for symptom relieving medication by 65 per cent (median values).
The results show corresponding effect to the results from the largest clinical trial programme ever conducted within allergy immunotherapy in adults which led to a European marketing approval for adults in 2006.
In addition, a significant effect on asthma symptoms were observed. Grazax reduced the combined asthma symptom score by 64 per cent. The asthma symptoms included were: coughing, wheezing, chest tightening/shortness of breath (dyspnoea) and exercise induced symptoms. Participants in the study also experienced a 67 per cent reduction in the number of days with asthma symptoms (median).
Currently a registration application for the paediatric use of Grazax is under submission in Europe.
Henrik Jacobi, MD, EVP of Research and Development at ALK-Abelló said, 'The data are remarkable and suggest Grazax has the potential to provide a new treatment choice in this area particularly among young patients whose symptoms may not be controlled adequately with available treatments. New therapy options are needed for treating grass pollen allergy because currently available therapies apart from allergy immunotherapy do not achieve long-term symptom remission. In addition, immunotherapy has the added bonus that it may prevent asthma in at risk children and halt the allergic march.'
Grazax is the first immunotherapy tablet that treats the underlying cause of grass pollen allergy and not only the symptoms. Only immunotherapy targets the underlying cause of the allergic disease, having the potential to result in long-term remission.
While long term studies are still being conducted on Grazax, the GT-12 results with Grazax in children show significant effects on asthma symptoms supporting hopes for a way to 'halt' the allergic march.
Grass pollen allergy is a health problem representing a significant social burden. At least 75 million people in the USA and Europe suffer from grass pollen allergy in the form of allergic rhinitis (hay fever) or allergic asthma - or both.
The majority of patients are only offered symptom-relieving medications that reduce symptoms temporarily but do not treat the allergy itself. In addition, 60-68 per cent of patients using symptom-relieving medications perceive them to be in the range of 'not at all effective' to 'moderately effective' on individual symptoms, according to a survey conducted by the European Federation of Allergy and Airway Diseases Patients Associations (EFA).
Grazax is a fast-dissolving, once-daily tablet-based allergy vaccine for home administration. The efficacy and safety of Grazax has been documented in the largest adult clinical study programme ever conducted within allergy vaccination.