- British drugmaker Vectura Group said on Tuesday that a late-stage study aimed at expanding the indication of its asthma treatment flutiform failed to demonstrate the drug's superiority over a common long-acting beta-agonist (LABA) monotherapy in treating chronic obstructive pulmonary disease (COPD).
- Vectura had hoped to use data from the Phase 3 trial to support an application to market flutiform for COPD in Europe.
- The company indicated the trial failure meant it would be unable to file for the indication, even though an analysis of secondary endpoints is still ongoing.
Vectura, along with its trial partner Mundipharma, tested flutiform against formoterol fumarate dihydrate, an API used as the LABA component in AstraZeneca's asthma drug Symbicort. Flutiform is a combination of corticosteroid and a LABA. Roughly 1,800 patients were randomized to take either a low or high dose of flutiform or formoterol fumarate dihydrate over the course of one year.
Patients who received flutiform did not see any superior reduction in annualized rates of moderate and severe COPD exacerbation, however.
"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," said James Ward-Lilley, CEO of Vectura.
Net sales of flutiform for its asthma indication have grown quickly, doubling to €144 million in 2015, mostly in the E.U. and Japan. Kyorin sells the drug in Japan while Mundipharma is responsible for marketing in Europe.
Most of the drugs for the treatment of COPD are combination products that include a corticosteroid and either a LABA or long-acting muscarinic antagoinist (LAMA). Many companies in the space have also been testing treatments that are a combination of LAMA/LABA, which is becoming the preferred treatment option. AstraZeneca gained approval of their COPD combo Bevespi Aerosphere in April. Meanwhile, several big setbacks have been seen in the space for steroid-LABA combinations, making COPD a tricky market to gain a foothold.