Vectura's asthma therapy misses primary endpoint in final stage trial

(Reuters) - Respiratory drug specialist Vectura Group Plc said its asthma therapy Flutiform had not met the primary endpoint in a phase III trial carried out by its European partner Mundipharma. Vectura shares were down 10 percent at 124.8 pence at 0706 GMT. They were the biggest losers on the London Stock Exchange on Tuesday. Flutiform had not shown "statistically significant" superiority in reducing the yearly rate of the worsening of moderate and severe chronic obstructive pulmonary disease (COPD), when compared to mono-component LABA treatment, Vectura said on Tuesday. Vectura said Mundipharma was currently analyzing the trial's other endpoints, but had indicated that the primary endpoint result would prevent it from making a regulatory filing for COPD indication in Europe. The final stage trial involved 1,767 randomly picked patients in 16 countries in a double blind study, where neither the patients nor the administrator know the critical aspects of the experiment, guarding against both experimenter bias and placebo effects. The primary endpoint compared the effects of Flutiform, used in an inhaler, to Formoterol Fumarate Dihydrate - used for the treatment of COPD including chronic bronchitis, Vectura said. "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," Chief Executive Officer James Ward-Lilley said. As an approved asthma treatment, Flutiform recorded a 42 percent rise in in-market net sales to 92.4 million euros ($103.3 million) in the six months ended June. ($1 = 0.8949 euros) (Reporting by Noor Zainab Hussain in Bengaluru; Editing by Sunil Nair)