AstraZeneca’s hopes for expanding severe asthma drug Fasenra into chronic obstructive pulmonary disease are officially lost.
Wednesday, the British drugmaker said the therapy had flopped a phase 3 trial—its second of two—testing the drug in patients with moderate to very severe COPD.
Fasenra missed the primary endpoint of the study, dubbed Terranova, failing to significantly cut down on episodes when symptoms suddenly worsened.
AstraZeneca made a similar announcement earlier this month after Fasenra fell short in a separate phase 3 study, Galathea, though at the time it said it would wait for the Terranova results to roll in before making any decisions.
Now, though, there’s not much left to do besides “analyze the complete data sets … to further understand these results,” R&D chief Sean Bohen said in a statement, adding that, “These results are disappointing.”
Fasenra’s dashed COPD prospects mark a big setback for AstraZeneca, which was looking to give respiratory rival GlaxoSmithKline a run for its money. Though GSK had a two-year head start with Fasenra’s in-class rival, Nucala, AZ execs hoped Fasenra’s less-frequent dosing could help it poach market share. It is dosed every eight weeks after the first three doses, a less frequent schedule than Nucala.
Unlike Fasenra, though, Nucala has already shown it can improve exacerbation rates. In a phase 3 study, the drug beat out placebo at paring down the frequency of moderate and severe episodes in patients with higher blood eosinophil counts, a biomarker targeted by this class of drugs. Now, Glaxo is waiting for a decision from the FDA—and if it gets a green light, it’ll give the company a major edge over AstraZeneca.
GSK is getting ahead outside of asthma and COPD, too. Back in December, it picked up an FDA go-ahead for Nucala to treat eosinophilic granulomatosis with polyangiitis (EGPA), a chronic rare disease caused by inflammation in the walls of blood vessels.