Results

AstraZeneca’s asthma drug tralokinumab goes 0 for 3 in PhIII as 2 more trials flop

You can write off just about all of the remaining value assigned to AstraZeneca’s asthma drug tralokinumab — if you hadn’t already done so. Outside of the cancer arena, AstraZeneca’s string of setbacks is continuing.

The pharma giant followed up yesterday’s news that its BTK drug Calquence (acalabrutinib) had scored an early approval at the FDA with a note writing off the last two Phase III studies of their IL-13 drug tralokinumab as failures.

Their therapy not only failed to reduce the annual exacerbation rate for asthma patients — for the second time — it also was unable to reduce the need for steroids.

AstraZeneca was clearly in trouble back in May, when its first Phase III on exacerbation rates flopped. But researchers held out hope that the addition of more Phase III data would allow them to pool the data and make it a success.

Sean Bohen

This drug also failed a Phase IIb trial for asthma, raising questions about why the company would go ahead and continue a major late-stage effort needed to get an OK in an intensely competitive field.

At the time researchers said they were encouraged by a subgroup analysis that pointed to success, a strategy that has a nasty habit of backfiring. The company quietly dumped the idiopathic pulmonary fibrosis program, but insisted that there was every reason to believe that tralokinumab would work in asthma.

On top of that, Roche’s drug lebrikizumab, also an IL-13, came up with a split decision in its two Phase III studies last year that amounted to a severe setback on that front. In August Roche dumped that drug, selling it to Dermira for $135 million in near-term cash and $1.24 billion in milestones as the biotech planned to repurpose it for atopic dermatitis.

“The results are disappointing as we had hoped that tralokinumab would benefit patients with severe asthma, which is a complex disease with limited treatment options today,” noted AstraZeneca CMO Sean Bohen in a statement.



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