Fornix’s allergy drug found effective in Phase II/III hayfever study

The results show that the highest of the three doses of Oralgen grass pollen covered by the study can bring about a substantial decrease in allergic complaints even in the first year of treatment and allows a significant reduction in the use of other anti-allergy medication. The study revealed clear dose-dependence: while various parameters measuring the severity of allergic complaints were significantly lower for the highest-dosage group compared with the placebo group, the two lower-dosage regimes did not meet the applicable statistical definition of efficacy. All the dosage regimes covered by the study were safe and were tolerated well.

The results of the study will be submitted to the Dutch Medicines Evaluation Board (CBG) to support the application for registration of Oralgen grass pollen. A follow-up study was started after the completion of study AB0602 to evaluate the efficacy and safety of Oralgen grass pollen over a second treatment year. Fornix expects to publish the results of the follow-up study by early 2009.

Study AB0602 was a multi-centre, randomized, double-blind, placebo-controlled Phase II/III study intended to evaluate the three different dosages of the product – 9,500 BU twice weekly, 9,500 BU daily and 19,000 BU daily (BU = biological unit) – in terms of side-effects profile and efficacy. The study involved 605 adult patients with a history of moderate to serious symptoms of grass pollen-related rhinoconjunctivitis (hayfever).

Cees Bergman, CEO of Fornix, said: “The results of the study will provide strong support for the registration procedure and are very relevant to the future development of our allergy-related activities in Europe.”