GlaxoSmithKline and Theravance have reported positive top-line data from four Phase III trials assessing a combination therapy for maintenance treatment of chronic obstructive pulmonary disease (COPD), pushing the once-daily therapy closer to a regulatory filing.
The studies, which involved more than 4,000 patients, include two 24-week efficacy trials comparing a combination of the long-acting muscarinic antagonist (LAMA) umeclidinium bromide and the long-acting beta-agonist (LABA) vilanterol - coded UMEC/VI by the firms - with its components and placebo.
According to the data, the combo showed statistically significant improvements when compared with placebo and the individual parts in both trials, which tested difference doses.
There were also two 24-week active comparator studies that pitted UMEC/VI against the Boehringer Ingelheim's widely prescribed LAMA Spiriva (tiotropium).
The first compared the efficacy and safety of two difference doses of UMEC/VI with vilanterol and Spiriva, which showed also showed statistically significant improvements on all counts.
The second looked at the efficacy and safety of both combination doses compared with umeclidinium bromide, which showed a numerical but not statistically significant improvement, and Spiriva, which did show a stastically significant improvement.
On the safety side, the firms said the most common adverse events seen in all treatment arms, including placebo, were headache, nasopharyngitis, upper respiratory tract infection, cough, oropharyngeal pain and back pain, while the incidence of cardiovascular adverse events and serious adverse events was similar in each group.
Filings from year end
All that's left now of the ongoing registration programme are a 52-week safety study and two replicate 12-week crossover exercise studies. If these complete successfully, GSK plans to kick off global regulatory submissions for UMEC/VI from the end of this year, which is ahead of schedule, it said.
“We are very encouraged by the results of these initial studies for our LAMA/LABA, an important cornerstone of our broad respiratory development portfolio," said Darrell Baker, SVP Respiratory Portfolio Optimisation Leader at GSK.
"These studies, together with our earlier dose-ranging work, give us confidence that this is a once-daily medicine with the potential to benefit many patients with COPD," he added.
Full results of the studies are to be presented at upcoming scientific meetings, the companies said.