Almirall and Forest Laboratories have published encouraging Phase III trial data for aclidinium bromide in chronic obstructive pulmonary disease, putting the drug on course for regulatory submissions in Europe and the USA later this year.
The six-month ATTAIN study evaluated the safety and efficacy of two doses of the inhaled therapy (200mcg and 400mcg twice daily versus placebo) in 828 patients with moderate-to-severe COPD.
The trial met its primary and secondary efficacy endpoints by delivering clinically significant improvements in lung function (measured by forced expiratory volume or FEV1) and COPD symptoms when compared to the control group.
The news comes around a year after Almirall decided against filing for approval of a once-daily formulation of aclidinium bromide in order to focus on twice-daily dosing, which it said was likely to provide "superior benefit" for COPD patients. In 2009 the drugmaker was asked by the US Food and Drug Administration to look at higher and more frequent dosing of the drug in additional studies.
Jorge Gallardo, chairman and chief executive officer at Almirall, said: "With these results, we anticipate regulatory filings for aclidinium BID monotherapy this year."
Meanwhile, Almirall and Forest also reported positive Phase IIb results with aclidinium bromide in a fixed-dose combination with long-acting beta agonist formoterol, putting them on track to start a Phase III trial programme in the second half of 2011.
If approved, aclidinium bromide will enter a market estimated to reach $13 billion by 2019, according to data from market research firm Decision Resources.
Fixed-dose combination regimens based on long-acting muscarinic antagonists like aclidinium bromide and LABAs are expected to put in a strong showing because they will likely offer greater bronchodilation than existing blockbuster therapies, such as GlaxoSmithKline's Advair/Seretide (salmeterol/fluticasone) and Boehringer Ingelheim/Pfizer's Spiriva (tiotropium).
As a result the new combinations should have a stronger effect on patient symptoms such as shortage of breath.