Almirall, Forest report more Phase III COPD data

Almirall S.A. (Madrid:ALM) and partner Forest Laboratories Inc. (NYSE:FRX) said twice-daily 400/12 ug aclidinium bromide/formoterol delivered via Almirall's Genuair inhaler met the co-primary endpoints in the Phase III AUGMENT COPD trial to treat chronic obstructive pulmonary disease (COPD). Specifically, the dose improved morning pre-dose trough forced expiratory volume in one second (FEV1) from baseline to week 24 vs. 12 ug formoterol (p<0.05) and improved FEV1 from baseline at one hour post-dose vs. 400 ug aclidinium bromide (p<0.0001). The twice-daily 400/6 ug fixed-dose combination of aclidinium with the long acting beta agonist (LABA) formoterol missed the morning pre-dose trough FEV1 co-primary endpoint (p>0.05), but met the FEV1 at one hour post-dose co-primary endpoint (p<0.0001).

Last month, the partners reported data from the identical Phase III ACLIFORM/COPD trial showing that both fixed-dose combinations of aclidinium/formoterol met the co-primary endpoints. The five-arm trials each enrolled about 1,700 patients with moderate to severe COPD to receive placebo, formoterol, aclidinium bromide, twice-daily 400/6 ug aclidinium/formoterol or twice-daily 400/12 ug aclidinium/formoterol (see BioCentury, April 16). ...