Almirall, SA and Forest Laboratories, Inc has received top-line results from ACCORD COPD II, a 12-week phase-III study comparing the efficacy and safety of inhaled aclidinium bromide, an investigative bronchodilator, to placebo in 544 patients with moderate to severe COPD.

This is the second of three double-blind placebo-controlled pivotal phase-III studies investigating twice-daily (BID) aclidinium bromide 200ug and 400ug. The improvement from baseline in FEV1, the primary endpoint, was statistically significant in the 200ug (p=0.019) and 400ug (p=0.001) BID dose groups, however, for the expected therapeutic dose, 400ug, the magnitude of effect compared to placebo, 72 mL, was less than that observed in three other studies; the similarly designed ACCORD COPD I phase-III trial reported in January this year, a previously reported 15-day phase-II trial comparing aclidinium 400ug BID to placebo or tiotropium 18ug once daily, and a recently completed seven-day phase-II trial comparing aclidinium 400ug BID to placebo or formoterol. Across these other trials the difference in FEV1 from baseline ranged from 124 mL to 186 mL.
 
Further analyses of the results of the present trial are ongoing. Aclidinium was well tolerated in this study with a profile that was consistent with prior studies. In addition, a third double-blind placebo controlled trial (ATTAIN) of the 400ug BID aclidinium dose of six months duration assessing efficacy and safety in patients with COPD is currently underway with results from that study expected to be available in 1Q 2011. The ATTAIN study, if positive, along with the previously reported ACCORD COPD phase-III trial of aclidinium BID, will serve as the core for the monotherapy US NDA and EU filings anticipated in mid-2011.
 
"We remain confident that the ongoing phase-III ATTAIN trial will confirm a clinical effect of aclidinium BID similar to that as reported in January of this year for the ACCORD COPD I trial and the phase-II comparison studies,” said Lawrence S Olanoff, president and chief operating officer of Forest Laboratories.
 
“We believe aclidinium bromide has the potential to be an important treatment option for the millions of COPD patients suffering with this debilitating disease” said Per-Olof Andersson, executive director Research and Development at Almirall.
 
Almirall, an international pharmaceutical company based on innovation and committed to health.

Forest Laboratories is a US-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives.