Almirall and Forest Laboratories reported possibly unexpected topline data from a second Phase III study evaluating twice-daily inhaled (BID) aclidiniun bromide in the treatment of chronic obstructive pulmonary disease candidate (COPD).
Results from the placebo controlled, 544-patient Accord COPD II study found that the lower 200 μg inhaled dose of aclidinium significantly improved FEV1 measures from baseline. However, the higher, supposedly therapeutic 400 μg dose had less of a beneficial effect than would have been expected from previous studies, including the similarly designed Phase III Accord COPD I study reported at the start of the year, and prior Phase II comparison trials. Data from Accord COPD II showed the magnitude of therapeutic effect of 400 μg aclidinium in comparison with placebo was just 72 mL. Across a range of other clinical trials the difference in FEV1 from baseline ranged from 124 mL to 186 mL. The partners say further analysis of the Accord COPD I trial data is ongoing.
A third Phase III study, Attain, is evaluating BID 400 μg administration over six months. Almirall and Forest hope the combined data from Accord COPD I and the ongoing Attain study will form the basis of regulatory submissions for aclidinium BID monotherapy, which are planned for submission in the U.S. and EU by mid-2011.
“We remain confident that the ongoing Phase III Attain trial will confirm a clinical effect of aclidinium BID similar to that reported in January of this year for the Accord COPD I trial and the Phase II comparison studies,” remarks Lawrence S. Olanoff, Forest president and CEO.
Forest has licensed U.S. rights to aclidinium bromide from Almirall, which retains rights to the rest of the world. The compound is being developed jointly by the two companies.