Almirall and Forest say their COPD drug aclidinium shows positive results and Ph III and Ph II studies

Spain’s largest drugmaker Almirall (ALM.MC) and US partner Forest Laboratories, (NYSE: FRX) have announced positive top-line results of ATTAIN, a six month double-blind placebo-controlled pivotal Phase III study comparing the efficacy and safety of inhaled aclidinium bromide 200mcg and 400mcg twice daily (BID) versus placebo, in 828 patients with moderate to severe COPD.

Aclidinium 200mcg and 400mcg produced statistically-significant increases from baseline in morning pre-dose (trough) FEV1 versus placebo at week 24 (99mL and 128mL, respectively; p<0.0001), which was the primary endpoint of the study for Europe, and at week 12 (77mL and 105mL, respectively; p≤0.0001) which was the primary endpoint for the USA.

All secondary endpoints demonstrated statistically-significant differences vs placebo for both doses. These endpoints included peak FEV1, and the percentage of patients achieving a clinically meaningful reduction in breathlessness (assessed by a 1 unit improvement in Transition Dyspnea Index) and the percentage of patients with improved health status (assessed by a 4-unit improvement in the St George’s Respiratory Questionnaire).