AstraZeneca’s triple-combination therapy has outperformed Symbicort and other two-drug inhalers in a phase 3 COPD trial. The trial’s success against eight out of nine lung function primary endpoints positions AstraZeneca to start filing for approval in the second half of the year.
Investigators enrolled 1,800 patients with moderate to very severe COPD and randomized them to take the experimental triple combination PT010 or one of three other products twice a day for 24 weeks. Patients in the other arms took one of AstraZeneca’s dual-combination COPD therapies, Symbicort and Bevespi Aerosphere, or an experimental two-drug inhaler, PT009.
PT010 outperformed the other drugs in terms of change in forced expiratory volume in one second (FEV1) at most of the time points assessed in the study. The exception was the comparison between PT010 and Bevespi Aerosphere at 24 weeks, when AstraZeneca saw a favorable, but not statistically significant, trend. The safety and tolerability of PT010 were as expected.
AstraZeneca is lining up regulatory filings on the back of these data. Submissions in China and Japan are penciled in for the second half of the year. And AstraZeneca is also considering filing for approval in the U.S. and Europe next year. Next year will also see the release of data from a larger trial that is assessing the effect of PT010 on COPD exacerbations.
The data, filings and subsequent commercial success will dictate the return AstraZeneca generates on a bet it placed in 2013. AstraZeneca landed the rights to PT010 by paying $560 million (€449 million) upfront to buy Pearl Therapeutics. The deal also featured $450 million in clinical and regulatory milestones tied to the success of Pearl’s stable of triple-combination therapies.
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One of the drugs covered by the deal, Bevespi Aerosphere, has already come to market. But PT010 gives AstraZeneca a chance to claim a share of the nascent market for triple-combination therapies.
“I expect the triple class of medicines to play an increasingly important role in addressing the needs of the many COPD patients who are currently undertreated or are receiving triple combination therapy as separate medicines in multiple devices,” Klaus Rabe, a University of Kiel professor and national coordinating investigator of the chronic PT010 trial, said in a statement.
Others share Rabe’s belief in the potential of triple COPD therapies, and as such AstraZeneca won’t have the market to itself. GlaxoSmithKline won FDA approval for its once-daily triple combination Trelegy Ellipta late last year.