Phase III trial flop scuttles Vectura's hopes for expanding Flutiform into COPD

Respiratory player Vectura can set aside its hopes of snagging a new COPD indication for its combination med Flutiform--at least for now.

Tuesday, the U.K. company said that its ICS/LABA med had flunked a Phase III trial, failing to beat a solo LABA treatment at reducing moderate and severe COPD exacerbations.

With that result in mind, partner Mundipharma says it won’t be able to file for a COPD nod in Europe, though it’s in the process of analyzing the trial’s other endpoints.


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The trial failure is a blow to Vectura, which was looking to pad the €144.4 million in sales that Flutiform pulled in during 2015. A COPD nod would have put the drug on a more even footing with meds such as GlaxoSmithKline’s Breo--known as Relvar in Europe--which won simultaneous asthma and COPD go-aheads from European regulators in November 2013.

As Chippenham-based Vectura was quick to note, however, all hope its not lost. Other inhaled ICS/LABA combo drugs have failed one head-to-head exacerbation-rate trial only to succeed in other studies, the company said in a statement.

Meanwhile, Vectura is looking for other ways to get ahead in the crowded respiratory field, which features heavyweights GSK and AstraZeneca. Vectura boasts partnerships with Novartis on respiratory therapies Ultibro and Seebri, and it has teamed up with Jordan’s Hikma to develop a generic version of Glaxo’s Advair.

The company also recently jumped on the “smart inhaler” bandwagon, inking a pact with Wisconsin’s Propeller Health to develop of an add-on sensor for Vectura’s lever-operated, multidose inhaler.

That sensor, along with Propeller’s companion analytics interface, will help patients and doctors better control respiratory disease, Vectura predicts, with patients becoming “more engaged with their care and better equipped to understand their disease and improve self-management,” it said in a May statement.

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