Spanish drugmaker Almirall and US group Forest Laboratories are close to filing their chronic obstructive pulmonary disease (COPD) inhaler Genuair with regulators after publishing a positive batch of late-stage trial data.
The groups said a six-month pivotal Phase III clinical trial of Genuair (Pressair in the US) - which delivers a fixed dose of alclidinium bromide and formoterol fumarate, two different bronchodilators with different modes of action - met both of its primary endpoints.
Both combinations of aclidinium/formoterol tested - 400/6mcg and 400/12mcg twice a day - demonstrated statistically significant improvements lung function, as measured by change from baseline in morning pre-dose trough FEV1 compared with formoterol 12mcg, and in FEV1 at one hour post-dose versus aclidinium 400mcg.
What's more, both treatment arms were well tolerated in the study, the most common side effects being nasopharyngitis and back pain, according to the firms.
Results of a second Phase III trial are expected over the coming weeks and, if successful, will support the groups' plans to file a New Drug Application with regulators on both sides of the pond.
"We expect this novel combination of aclidinium/formoterol to offer patients a new option in COPD treatment," said Bertil Lindmark, Chief Scientific Officer at Almirall, stressing: "In addition to the improved efficacy shown in this study, the safety profile was comparable to placebo".
COPD is a common, progressive, and debilitating lung disease characterised by persistent airflow limitation that makes it hard to breathe. The World Health Organisation has described COPD as a global epidemic, with an estimated 64 million people suffering from the condition around the globe.
FDA advisors to rule on Breo
Meantime, on Wednesday (April 18), a US Food and Drug Administration advisory committee will make its recommendation regarding GlaxoSmithKline/Theravance's combination COPD drug Breo (fluticasone furoate/vilanterol).
Documents issued by agency staffers before the hearing state that Breo's overall safety was consistent with similar drugs, although there are some concerns about efficacy.