Almirall and partner Forest Laboratories have reported positive results from a late-stage study of their investigational chronic obstructive lung disease drug aclidinium bromide.
In the first of three Phase III studies investigating the twice-daily (BID) administration of aclidinium in COPD patients, two doses of the drug (200mcg and 400mcg) produced statistically significant changes from baseline in morning pre-dose FEV1 (forced expiratory volume in the first second) versus placebo at week 12, the primary endpoint for the study. Aclidinium administration at both doses also produced a significant in peak FEV1, the secondary endpoint, as early as day one, which was sustained for the duration of the 561-patient study.
The Spanish drugmaker said that these top-line results are consistent with those obtained in a 15-day Phase II study comparing the drug with Boehringer Ingelheim/Pfizer’s COPD drug Spiriva (tiotropium) and placebo. Per-Olof Andersson, head of R&D at Almirall, said the results from both the Phase II and III trials indicates that aclidinium BID “provides significant bronchodilation and is well tolerated in patients with moderate to severe COPD”.
The path towards submission of the drug has not been a smooth one and in March last year the companies said that following consultation with the US Food and Drug Administration, additional clinical studies needed to be conducted on aclidinium to “provide further support for the selected regimens, including higher and/or more frequent doses”.
These trials have got off to a good start and Almirall shares were up 3.9% to 9.51 euros at 10.15 this morning (UK time).
