The trials are designed to test the safety and efficacy of pre-seasonal treatment with PreHistin on moderate to moderately severe seasonal ragweed allergy patients.
The phase III trials involved 1,551 patients who received either placebo or a 3.3 mg sublingual dosage of PreHistin twice daily for three weeks prior to the onset of the ragweed allergy season and for an additional three weeks into the allergy season. Symptom diaries were maintained for an additional four weeks following treatment to determine duration of effect.
Cobalis anticipates reporting efficacy results from the pivotal trials in the first quarter of 2007.
In the US alone, approximately 40 million people suffer from allergic rhinitis. Ragweed is the single most common seasonal allergen, affecting up to 75% of those with allergic rhinitis. Current therapeutic options are mainly limited to symptomatic therapies and conventional allergy immunotherapy.