Vectura said today that its marketed asthma drug flutiform® has failed a Phase III trial intended to support an additional indication in Europe of chronic obstructive pulmonary disease (COPD).
Vectura’s European partner Mundipharma oversaw the trial, which missed its primary endpoint by failing to show statistically significant superiority in lowering annualized rates of moderate and severe COPD exacerbations compared to long-acting β2-agonist (LABA) treatment alone.
During the trial, 1767 patients in 16 countries received either flutiform 250/10 µg (two puffs twice per day), flutiform 125/5 µg (two puffs twice per day), or formoterol fumarate dihydrate 12 µg (one puff twice per day) for 52 weeks.
Mundipharma has indicated that the disappointing Phase III results will preclude a regulatory filing in Europe to add a COPD indication to flutiform, Vectura acknowledged.
Mundipharma has marketing rights to flutiform for most of the world outside North America and Japan and Kyorin has marketing rights in Japan.
flutiform combines fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS), and the LABA formoterol fumarate in an aerosol inhaler incorporating Vectura's proprietary SkyeDry™ technology.
“COPD is a complex and highly variable disease and these trial results highlight the challenge in demonstrating reductions of exacerbations with ICS/LABA combinations in today's treatment environment,” Vectura CEO James Ward-Lilley said in a statement. “Whilst this result is disappointing, flutiform continues to grow strongly based on the approved asthma indication, which continues to underpin our expectations for future growth of the product.”
Net sales of flutiform have climbed to €92.4 million ($103.2 million) during the first 6 months of this year, after reaching €144.4 million ($161.2 million) in 2015 following the launch of the 120-puff version in Japan in December 2014.
Vectura also cited several previous studies with other inhaled ICS/LABA combinations in COPD that showed varying results.
Vectura’s update on flutiform came 5 months after the company announced it had agreed to a £441.3 million ($578.4 million) merger with Skyepharma, which will create a combined company specializing in respiratory treatments. Vectura said it will discuss progress toward its integration with Skyepharma on September 7th at its Annual General Meeting.