AstraZeneca $AZN started the day with news that its three-in-one chronic obstructive pulmonary disease inhaler has turned out positive top-line results in a Phase III trial. But they may have arrived too late with too little to directly challenge GlaxoSmithKline in the field.
Compared with dual combination therapies, twice-daily doses of PT010 — which contains budesonide, glycopyrronium and formoterol fumarate — demonstrated statistically significant improvement in eight out of nine lung function primary endpoints, the UK pharma giant said, without providing numbers. A formulation of glycopyrronium and formoterol fumarate makes Bevespi Aerosphere, currently approved for COPD.
AstraZeneca has made respiratory ailments one of its core focuses in R&D, with some mixed results capped by the success of benralizumab, recently approved for asthma. AstraZeneca picked up PT010 all the way back in 2013, with their acquisition of Pearl. But it’s largely been kept out of the spotlight. The big question now is whether the pharma giant has the data needed to challenge GSK’s big once-daily triple COPD therapy Trelegy Ellipta, which has a big head start and an easier dosing regimen.
AstraZeneca is looking to tap into a gap in treatment options that Klaus Rabe, national co-ordinating investigator of the KRONOS trial, spelled out:
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.
With the full results to come in a medical meeting, AstraZeneca plans on making regulatory submissions in Japan and China in the second half of 2018. Potential submissions in the US and Europe are to follow in 2019, when the readout for another trial is due.
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