AstraZeneca’s been struggling to measure up to archrival GlaxoSmithKline in the respiratory department, and the latest data on its triple-combination COPD candidate may not do much to help that situation.
Over the weekend, the British drugmaker said the three-in-one drug, dubbed PT010, had met eight of nine primary endpoints in a phase 3 trial pitting it against AZ dual combos Bevespi Aerosphere and Symbicort Turbuhaler. But when it came to cutting down the rate of instances when symptoms suddenly worsened, it couldn’t outdo its two-drug predecessors.
As AstraZeneca was quick to point out, PT010 did post small reductions in those instances of COPD exacerbation, but they weren’t large enough to pass the statistical significance threshold. The prospect also significantly pared down the rate of exacerbations against Bevespi Aerosphere in a patient subpopulation, hitting a secondary endpoint of the study.
Still, the miss doesn’t bode particularly well for AZ, which faces a looming showdown between PT010—a med it acquired with its 2013 buyout of Pearl Therapeutics for $1.15 billion—and GlaxoSmithKline’s Trelegy Ellipta. Approved last September, Trelegy will also have a significant market lead by the time PT010 can potentially snag a green light, with AZ anticipating making its first regulatory submissions for the up-and-comer later this year.
That lead is one GlaxoSmithKline’s executives have predicted could lock up its position in the respiratory field for years to come.
“I think if you decide that your triple of choice is the GSK triple, then why wouldn't you start with a double of GSK? Why on earth would you start with somebody else's double?” former CEO Andrew Witty asked on a 2016 conference call, predicting that Trelegy would be “the thing that really clinches the market.”
Meanwhile, AstraZeneca has been struggling to challenge GSK with its other respiratory therapies this year, too. In August, Bevespi failed to beat out Glaxo challenger Anoro in a head-to-head trial, and AstraZeneca’s severe asthma drug Fasenra hasn’t been able to come up with the positive COPD data GSK’s Nucala already has on hand.