Almirall, S.A., an international pharmaceutical company based on innovation and committed to health, said that the company and its US partner Forest Laboratories, initiated a phase III clinical programme of the fixed dose combination (FDC) of aclidinium bromide and formoterol fumarate twice daily (BID) delivered in the Genuair inhaler, for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD).

The phase III programme involves approximately 3,500 patients with moderate to severe COPD and consists of two large pivotal studies -one conducted mainly in Europe and another in North America- evaluating the efficacy and safety of the FDC of aclidinium plus formoterol during 24 weeks, as well as a long-term safety study of 52 weeks which is also performed in North America. Protocols of these clinical trials have been designed to fulfil both EMA and FDA requirements.

The studies’ endpoints include bronchodilation parameters (i.e. FEV1), symptom measurement (i.e. breathlessness assessed by Transition Dyspnoea Index -TDI-), health status (ie quality of life assessed by the St George’s Respiratory Questionnaire -SGRQ-) and COPD exacerbations.

“After the filing of aclidinium monotherapy in Europe and the USA, the start of this global Phase III programme of the fixed dose combination of aclidinium and formoterol, in more than 25 countries, means that Almirall is progressing in expanding the aclidinium franchise. We are aiming to provide innovative treatment options for patients suffering from debilitating respiratory diseases, as is the case of COPD”, said Bertil Lindmark, chief scientific officer at Almirall.

In January, Almirall and Forest announced positive results of two Phase IIb dose-ranging studies comparing fixed-dose combinations to aclidinium bromide, formoterol and placebo, administered BID in patients with stable moderate to severe COPD patients. In both studies, the fixed dose combination demonstrated improved bronchodilation compared to aclidinium and formoterol alone.

Aclidinium bromide is a novel, long-acting inhaled muscarinic antagonist -sometimes referred to as an anticholinergic-, which has a long residence time at M3 receptors and a shorter residence time at M2 receptors, and which is designed to be rapidly broken down in plasma, leading to high topical efficacy but low propensity for systemic anticholinergic effects. When given by inhalation, aclidinium leads to bronchodilation by inhibiting airway smooth muscle contraction. Aclidinium bromide is rapidly hydrolysed in human plasma to two major inactive metabolites.

The fixed dose combination of aclidinium and formoteroldelivers improvement in bronchodilation and symptoms from both compounds and it will be administered twice daily using the novel, state-of-the-art, user-friendly multidose dry powder inhaler (MDPI), Genuair®, from Almirall. This inhaler was designed with a “click and colour” feedback system which, through a 'coloured control window' and an audible click, indicates that the patient has inhaled the dose correctly. It also incorporates significant safety features such as a visible dose indicator, an anti-double-dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.

Forest Laboratories, Inc. licensed US rights for aclidinium bromide from Almirall, and Kyorin for Japan, while Almirall maintains rights for the rest of the world. Almirall and Forest are jointly involved in the development of the compound.

Genuair is a trademark owned by Almirall, S.A. and is pending approval from the appropriate regulatory authorities.