Danish drugmaker ALK-Abello has reported positive results from the third treatment year of the GT-08 trial of Grazax, its tablet-based vaccine against grass pollen allergy. The study found that the highly statistically-significant clinical effect from the first and second years of treatment is sustained through the third year and even increases when taking into account the differences between the three pollen seasons. Furthermore, an increasing, positive effect on the immune system was also observed, the firm noted.
In the third treatment year, Grazax significantly reduced hay fever symptoms and the use of symptom-relieving-medication (p<0.001). Symptoms decreased 37% while the use of symptom-relieving medication dropped 60%. The reduction of symptoms and use of medication is measured as median values relative to a placebo group in which patients had unrestricted access to symptom-relieving medication. Thus, the effect of Grazax comes in addition to that from placebo and symptom-relieving medication.
Following the three-year treatment period, a further efficacy analysis was made taking into account the differences between the three pollen seasons. This found that the clinical effect increases significantly over the three years of treatment. In addition, blood samples from patients show a significant, increasing effect on the immune system indicating an increasing tolerance to grass pollen, the firm noted.
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