GlaxoSmithKline and Theravance eye Phase III for another COPD contender

The blockbuster duo of GlaxoSmithKline ($GSK) and Theravance ($THRX) are pushing a new respiratory combo therapy into late-stage study, pooling the active ingredients from its last two approved COPD treatments to create a once-daily inhaler.

The plan is to enroll 10,000 patients to see if a combination of Breo Ellipta and Anoro Ellipta can better reduce the rate of severe COPD flare-ups than the two treatments can alone.

The new treatment combines the corticosteroid fluticasone furoate, found in Breo, with umeclidinium, Anoro's long-acting muscarinic antagonist, and adds in the long-acting beta2-adrenergic agonist vilanterol, which is found in both.

The study, dubbed IMPACT, will dose patients with either Breo, Anoro or the new cocktail, with a primary endpoint of reducing the annual rate of exacerbation and secondary goals of improving lung function and time to first exacerbation.

This marks the first Phase III trial of a daily, three-part treatment for COPD, the companies said. Prescribing data shows that many patients with the disease are receiving three medicines in different inhalers, and the new treatment is an effort to meet their needs with a single device, Theravance CEO Rick Winningham said.

"The start of the IMPACT study marks a significant milestone in our development program with GSK, and we are excited about the potential opportunity for a triple combination treatment approach," Winningham said in a statement. "This Phase III program has the potential to demonstrate the safety and efficacy profile of a new and important therapy that could deliver additional benefits and convenience to the growing number of adults living with COPD worldwide."

If successful, the combo therapy would mark the third major approval in a 12-year relationship between the two companies. Approved last year, Breo and Anoro are expected to peak at more than $3.5 billion in sales combined, and, in addition to the combo inhaler, the two are working on a bifunctional muscarinic antagonist-beta agonist that has shown promise in mid-stage trials.

Meanwhile, the COPD space is rapidly crowding as Novartis ($NVS), Boehringer Ingelheim and AstraZeneca ($AZN) advance next-generation candidates for the disease. But GSK is betting there's room for more than one blockbuster. COPD affects about 27 million people in the U.S. alone, the company says, and Citigroup estimates the market for treatments will jump from $10 billion in 2013 to $14 billion in 2018.

- read the statement