Spanish pharmaceutical company Almirall hopes to improve treatment for (COPD) sufferers with its development of a dry powder multi-dose inhaler featuring the muscarinic antagonist compound aclidinium bromide.
The treatment, which is the subject of multi-centre and multinational Phase III clinical trials, has been designed to speed up therapeutic effect and encourage correct device use and compliance.
According to pharmacology results presented at the European Respiratory Society (ERS) Annual Congress in September 2007, aclidinium has strong selectivity and a long duration of action as its target M3 receptors in the airway, but is rapidly cleared from the plasma.1 Onset of action is said to be within 15 minutes and lasting for 24 hours, the company says.
Speaking about the compound, Gonzalo de Miguel of Almirall, said: " It binds very strongly to the receptor in the lungs and lasts there for a long time But when aclidinium bromide enters into the blood stream, it is metabolised and the likelihood of aclinimide reaching other areas such as the heart, bladder or gut is very low. Other products on the market stay in the blood for hours or days."
The device has been developed through the company's alliance with one of the company's divisions - Almirall-Sofotec and uses a "press and inhale" concept. The device contains 30 doses with a visible does indicator as well as an "integrated feedback system" which turns from green to red - indicating that a dose has been taken. Once used correctly, the device has a "lock-out system, which prevents the user from taking a second dose or overdosing.
Aclidinium is being evaluated in two large phase III studies known collectively as Aclidinium Clinical Trial Assessing Efficacy and Safety In Moderate to Severe COPD Patients (ACCLAIM). Approximately 1,600 COPD patients recruited from 23 countries. Results are due in the second half of 2008. The company is working with Forest Laboratories in the US on the development of the compound and expects the compound to be filed by 2009.
Meanwhile, the company is claiming promising results from a study into the 24-hour efficacy of a new compound for asthma/Chronic Obstructive Pulmonary Disease (COPD). The once daily-inhaled Long Acting beta Agonist (LABA) contains the compound LAS100977 and has been successful.
The first patient study with the compound was a single dose, double-blind placebo and active (salmeterol 50mg bid) controlled cross over study in 25 asthma patients, exploring different doses of LAS100977 given once daily.
Reference
1. Gavalda A, Miralpex M, Ramos I et al. Aclinindium bromide, a novel muscarinic receptor antagonist combining long residence at M3 receptors and rapid plasma clearance. ERS Annual Congress, September 2007