Almirall and partner Forest Laboratories reported new Phase III trial data demonstrating significant benefits of inhaled aclidinium bromide therapy in patients with chronic obstructive pulmonary disease (COPD). The firms project filing for regulatory approval of the drug as monotherapy in both the U.S. and Europe during mid-2011. Almirall and Forest in parallel announced positive results from Phase IIb studies evaluating a fixed-dose combination of aclidinium bromide and formoterol in the treatment of COPD. The partners say they now project starting Phase III studies with the combination therapy during the second half of 2011. Under terms of their aclidinium collaboration and licensing deal, Forest has rights to develop and commercialize aclidinium for the U.S. market.
The newly reported placebo-controlled Phase III Attain study evaluated two doses of aclidinium monotherapy administered twice daily, in 828 patients with moderate to severe COPD. Both doses of the drug significantly boosted patients’ morning (pre-dose trough) FEV1 at week 24 (the primary endpoint of the study for Europe) and week 12 (the primary endpoint for the U.S.). All secondary endpoints were also met, including peak FEV1, and the percentage of patients achieving clinically meaningful reductions in breathlessness. Throughout the trial aclidinium therapy resulted in significant changes from baseline in trough FEV1, at each time point, the firms stress.
The Attain study results back up the positive data generated by the Phase III Accord COPD I study, which was reported in early 2010. Almirall and Forest have been on something of tenterhooks in anticipation of the Attain results, however, as in October 2010 data from another Phase III aclidinium monotherapy trial, Accord COPD II, suggested the higher therapeutic dose of the drug resulted in less of a beneficial effect on FEV1 than would have been expected on the basis of previous trial data.