Almirall reveals promising phase II data with its once-daily, long-acting, low systemic exposure, inhaled anticholinergic LAS34273
Barcelona
The dose-range study assessed efficacy, safety and tolerability of inhaled LAS34273 administered once-daily in patients with moderate to severe stable chronic obstructive pulmonary disease compared with placebo. This large study was composed of a total of 48 centres across seven European countries and it included 464 randomised patients in the trial.
Results demonstrate that LAS34273 has a sustained 24-h bronchodilator effect; an effect that was rapidly observed and was maintained over the 4 weeks of the trial, indicating absence of tachiphylaxis. LAS34273 was designed to have a very low systemic exposure and the incidence of adverse events reported was very low in all treatments arms with no relation with doses of LAS34273. This large scale dose-range study has shown a clear dose-response effect with no safety dose-limiting factors.
In addition, extensive cardiovascular safety clinical testing has demonstrated that LAS34273 does not produce any specific effect on QTc interval or any other cardiovascular parameter, as compared to placebo, at either the potential therapeutic dose or four times greater.
LAS34273 has demonstrated a fast and sustained 24-h bronchodilator effect with a favourable side effect profile. Almirall is now planning to start Phase III in 2006.
Chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease state characterized by airflow limitation that is not fully reversible.
The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lung to noxious particles of gases, primarily caused by cigarette smoking.It is estimated that the disease is prevalent in approximately 4% of the population of the
Almirall, a leading company committed to health
Almirall, a leading company committed to health in society, is a consolidated international pharmaceutical company that discovers, develops and commercialises drugs from its own R&D, as well as licensed drugs, with the aim of improving health and quality of life.
Almirall focuses its drug discovery resources in therapeutic areas related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), psoriasis and rheumatoid arthritis.
Almirall will be investing 500 million Euros in R&D over the next five years. This is the largest investment in this area by a Spanish pharmaceutical company. Forecasts for total sales in 2005 amount to 946 million Euros.
Almirall, whose headquarters are in