The prospects for aclidinium, Almirall’s investigational treatment for chronic obstructive pulmonary disease, are not as gloomy as some analysts have been predicting, according to a number of experts at the European Respiratory Society congress in Berlin.

The Spanish drugmaker’s shares have taken a bashing since the firm announced results from two global Phase III studies of aclidinium, a novel long-acting inhaled anticholinergic, in September. In both the ACCLAIM/COPD I&II studies, the drug, taken once-daily, showed a statistically significant difference versus placebo using a standard measure of pulmonary function, FEV1 (the volume of air that is exhaled in the first second). The dosage used was 200mcg.

Aclidinium significantly improved the percentage of patients showing a clinically relevant improvement in health-related quality of life compared with placebo as measured by the St George's Respiratory Questionnaire. However, ACCLAIM/COPD II, which involved 1,647 patients from 23 countries, did not reach statistical significance for SGRQ at week 52, but did achieve it at all previous time-points.

This led to fears that the drug, which is partnered with the USA’s Forest Laboratories, may struggle to get approval and challenge Boehringer Ingelheim's blockbuster Spiriva (tiotropium), which is marketed by Pfizer, in the COPD market. However another look at the data at a symposium at the Berlin meeting suggests that talk of the demise of aclidinium may be premature.

Bartolome Celli, professor of medicine at Tufts University in Boston, reviewed the data and said that the findings follow a very similar pattern to the results of the four-year 6,000-patient UPLIFT trial of Spiriva that were also presented in Berlin. Furthermore, he noted that aclidinium demonstrated very low levels of dry mouth, one of the most common side effects of Spiriva.

Dr Celli acknowledged that there is a dosing issue and Joan Heras, Almirall’s director of medical and regulatory affairs in Spain, told Pharma Times World News that discussions about initiating a Phase II trial to figure out the optimum dosage are ongoing with Forest. An announcement about that and a fresh Phase III is expected in the next couple of days.

At the end of the symposium, Dr Celli addressed a question to a panel of COPD experts which suggested trying 400mcg or 200mcg twice a day. One panelist, Alvar Agustí of the Hospital Universitari Son Dureta in Palma de Mallorca, noted that this may be an option, adding that “the dogma of once-daily dosage for symptomatic diseases may need to be revisited”.

Since the Berlin meeting, Almirall shares have started to climb again and Dr Heras noted that Forest is backing aclidinium as are many members of the scientific community. Dr Celli appears to be a fan and when gremlins attacked the slides on his computer momentarily, he quipped: “To cut a long story short, it’s a great drug”.