Phase III Clinical Trial Flop Scuttles Vectura ‘s Desires for Broadening Flutiform into COPD
British-based pharmaceutical company, Vectura can set aside its hopes of getting a new COPD (Chronic Obstructive Pulmonary Disease) indication for its combination medicine Flutiform.
On 30th August, the company stated that its ICS/LABA medicine had flunked a Phase III clinical trial, unable to beat a solo LABA therapy at decreasing moderate and severe COPD exacerbations.
With that outcome in mind, partner Mundipharma states that it won’t be capable to file for a COPD nod in Europe, although it’s in the approach of examining the trial’s other outcomes.
The trial failure is a setback to Vectura, which was seeking to pad the €144.4 million in sales that Flutiform drawn in during 2015. A COPD nod would have placed the drug on a more even footing with medicines such as GlaxoSmithKline’s Breo which is known as Relvar in Europe, won simultaneous asthma and COPD go-aheads from EU regulators in November 2013.
Vectura was quick to observe, however, all desire it is not lost. Other inhaled ICS/LABA combination drugs have unsuccessful one head-to-head exacerbation-rate trial only to be successful in other studies, the firm said in a statement.
Meanwhile, Vectura is searching for other approaches to get ahead in the crowded respiratory field, which features heavyweights GSK and AstraZeneca. Vectura boasts joint ventures with Novartis on respiratory treatments Ultibro and Seebri, and it has joined with Jordan’s Hikma to develop a generic edition of Glaxo’s Advair.
The company also lately jumped on the “smart inhaler” bandwagon, inking a pact with Wisconsin’s Propeller Health to develop of an additional sensor for Vectura’s lever-operated, multidose inhaler.
That sensor, together with Propeller’s companion analytics interface, will assist sufferers and physicians better control respiratory condition, Vectura predicts, with sufferers becoming “more engaged with their care and much better equipped to recognize their disease and enhance self-management,” it mentioned in a May statement.