ALK-Abelló A/S (ALK)(CPH:ALKB), a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment, reported on Thursday the successful outcome of a pivotal Phase III clinical trial of its tree allergy sublingual immunotherapy (SLIT) tablet, with the trial meeting its primary efficacy endpoint.
Reportedly, this tree SLIT-tablet is important to ALK's efforts to develop a full tablet portfolio for people suffering from the most common respiratory allergies. Currently, ALK is the only company that has completed Phase III clinical development with a tree SLIT-tablet.
ALK had initiated the Phase III clinical trial in 2016 to evaluate the efficacy and safety of the tree SLIT-tablet compared with placebo in adult and adolescent patients with birch pollen allergic rhinitis and/or conjunctivitis. The trial was a randomised, placebo-controlled, double-blind, multi-centre trial involving 634 patients aged 12-65 years in eight European countries. A preceding Phase II trial in an environmental exposure chamber showed that the tablet significantly reduced patients' symptoms in response to both birch and oak pollen compared with placebo.
According to ALK, the primary endpoint of the trial was the daily total combined score, which is the sum of the allergic symptom score and the use of symptom-relieving medication, measured during the birch pollen season.
ALK expects to submit a European and possibly also a Canadian registration application for the tree SLIT-tablet in 2018.
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