AstraZeneca’s respiratory group spells out some setbacks in its latest PhIII readout for GSK COPD rival PT010

AstraZeneca $AZN fielded the Phase III data on its new triple-drug combination COPD therapy that it intends to use to challenge GlaxoSmithKline. And the pharma giant has some problems to work out.

As reported near the beginning of the year, AstraZeneca’s KRONOS study offered positive results for PT010 (budesonide/ glycopyrronium/formoterol fumarate) compared to Bevespi Aerosphere and Symbicort, two 2-drug therapies in the field across a range of endpoints. But on closer look their contender to take on GSK’s Trelegy failed to significantly distinguish itself in the rate of moderate or severe COPD exacerbations versus PT009 and Symbicort and also failed the 24-week comparison on FEV1 response with Bevespi.

Colin Reisner

Researchers highlighted a numerical superiority over PT009 and Symbicort, but at 18% and 17% couldn’t prove that it wasn’t by chance.

All that will likely make it much tougher for AstraZeneca to play catch-up with Trelegy — an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA) — which has a big lead after getting a green light in 2017.

That will likely be sharply disappointing inside AstraZeneca, which paid $560 million upfront to bag Pearl Therapeutics back in 2013, with a clear interest in advancing new drugs — led by Bevespi (PT003) — to help build the respiratory portfolio. The company has touted PT010 as a top late-stage effort. But it’s also garnered considerable enthusiasm for tezepelumab, a “breakthrough” asthma drug that’s attracted considerable attention.

The new batch of data arrives just days after AstraZeneca was forced to explain that its drug Bevespi Aerosphere (glycopyrronium/formoterol fumarate) couldn’t beat out GSK’s Anoro (umeclidinium/vilanterol) on peak forced expiratory volume in one second (FEV1). Measuring trough FEV1, the other co-primary endpoint in the study, AstraZeneca’s inhaler performed worse. 

“We are encouraged by the results of the KRONOS trial which demonstrate PT010’s efficacy in improving lung function and its potential value as a triple combination therapy for patients with COPD,” said Colin Reisner, head of respiratory, global Medicines for AstraZeneca. “Importantly, PT010 also halved the rate of moderate or severe exacerbations compared to glycopyrronium/formoterol fumarate and we look forward to the ETHOS exacerbation trial results in 2019 to further characterise PT010.”

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Recursion Pharmaceuticals Salt Lake City, UT
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