BARCELONA and NEW YORK, January 4, 2011 /PRNewswire/ --
- ATTAIN results confirm clinically significant bronchodilation and improvement ofsymptoms in COPD patients treated with aclidinium bromide twice daily - Regulatory filings in Europe and USA for aclidinium bromide monotherapy are planned for mid 2011 - Positive results of two Phase IIb studies with the fixed dose combination of aclidinium bromide and formoterol will enable Phase III to start in second half 2011
Almirall, S.A. (ALM.MC) and Forest Laboratories, Inc. today 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 200 micrograms and 400 micrograms twice daily (BID) versus placebo, in 828 patients with moderate to severe COPD.
Aclidinium 200 micrograms and 400 micrograms 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 US.
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).
Additionally, throughout the entire study, aclidinium produced statistically significant changes from baseline in trough FEV1 vs placebo at each time-point, which ranged from 77mL to 105mL for aclidinium 200 micrograms and from 105mL to 140mL for aclidinium 400 micrograms.
Aclidinium was well tolerated in this study. The incidence of adverse events and serious adverse events was similar across the three study treatment arms.
"We are very pleased with these results which demonstrate that aclidinium provided consistent bronchodilation and symptom control in COPD for patients suffering from this debilitating disease", said Jorge Gallardo, Chairman and Chief Executive Officer at Almirall. "With these results, we anticipate regulatory filings for aclidinium BID monotherapy this year".
Regulatory submissions in Europe and the US for aclidinium bromide monotherapy are both planned for mid 2011.
Aclidinium and formoterol fixed dose combination Phase IIb Studies
Two Phase IIb dose-ranging studies comparing fixed-dose combinations (aclidinium bromide/ formoterol) to aclidinium bromide alone, formoterol alone and placebo, administered BID in patients with stable moderate to severe COPD, have also been successfully completed. Both studies showed statistically significant (p<0.001) differences for the fixed dose combination 2 on the primary endpoint versus placebo (normalized AUC 0-12 hours FEV1). The fixed dose combinations provided improved bronchodilation compared to aclidinium and formoterol alone. Following regulatory consultations, Phase III with the fixed dose combination will commence in the second half of 2011.
"Together with our partner Almirall, we are delighted with the ATTAIN results which confirm the efficacy reported in the ACCORD COPD I study. We are also encouraged by the results achieved with the fixed dose combination of aclidinium and formoterol in the Phase IIb studies, a combination of two bronchodilators, each with a different mode of action. We believe that aclidinium, a proprietary long-acting inhaled muscarinic antagonist, and formoterol, a long-acting inhaled beta agonist may be a desired combination for the treatment of COPD," said Howard Solomon Chairman and Chief Executive Officer of Forest Laboratories.