GSK And Theravance Announce Positive Phase 3 COPD Trial Results

GlaxoSmithKline and Theravance announced positive data from two studies investigating Incruse Ellipta as part of a combination treatment in patients with chronic obstructive pulmonary disease (COPD).

Incruse Ellipta is an anticholinergic, also known as a long-acting muscarinic antagonist (LAMA), approved by the FDA for the long-term once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

Two 12-week double-blind, placebo-controlled, multicenter, and randomized Phase III studies enrolled 1,238 patients with a history of COPD. The studies showed that COPD patients who received Incruse Ellipta in addition to Relvar/Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) saw more improvement in lung function (FEV1) compared to patients receiving FF/VI added to placebo. Relvar/Breo Ellipta is an inhaled corticosteroid/long-acting beta2-agonist combination.

Darrell Baker, SVP and head of global respiratory franchise at GSK, said that the results support the evidence base of the drug’s efficacy and safety profile. “These studies are also the first to investigate the combined effect of two of the newest medicines from our respiratory portfolio, both of which provide 24 hour efficacy. We will continue to progress our research to expand our understanding of how the combined use of these medicines may provide physicians with another treatment approach to meet the individual needs of their patients.”

Chronic obstructive pulmonary disease is an umbrella term that includes chronic bronchitis, emphysema or both. The disease is characterized by obstruction to the airflow that interferes with normal breathing. Most people afflicted with COPD are in their early forties when the disease’s symptoms begin to manifest.

Rick Winningham, Theravance CEO, said, “We are pleased with the positive data from these two studies evaluating an open triple therapy, Incruse added to Relvar/Breo Ellipta. With the data reported today, we have further strengthened our understanding of Relvar/Breo Ellipta.”

GSK said it will present complete results of the studies at a future scientific meeting.