Almirall/Forest complete COPD trials

Spanish drugmaker Almirall and USA-based Forest Laboratories have completed the Phase III ACCLAIM trials of their aclidinium bromide in patients suffering from chronic obstructive pulmonary disease.

The double-blind, multicenter, parallel-group, placebo-controlled studies evaluated the efficacy and safety of the candidate in 1,640 patients with moderate-to-severe COPD, who were over 40 years of age with at least a 10 pack-a-year smoking history. The primary endpoint of both trials was pre-dose forced expiratory volume in one second versus placebo. Top-line results from both of the ACCLAIM studies will be made available in the third quarter of this year.

Aclidinium bromide is a novel inhaled anticholinergic bronchodilator for the once-daily maintenance treatment of COPD. Almirall has licensed the US rights for the candidate to Forest, yet retains international rights. The companies are jointly involved in the development of the compound.