Innoviva-GSK project Trelegy Ellipta meets main endpoint in asthma pivotal trial

A combination drug-device therapy developed by GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) for asthma, Trelegy Ellipta, met the primary endpoint in its pivotal trial, the companies said last week.

The Trelegy Ellipta inhaler is designed to deliver a single daily dose of three drugs – fluticasone furoate, umeclidinium and vilanterol – to patients with uncontrolled asthma. The 2,436-patient Captain trial compared Trelegy Ellipta with Relvar/Breo Ellipta, consisting of just fluticasone furoate.  The study was randomized, double-blinded and active-controlled along six parallel treatment arms with roughly 400 patients in each, the companies said, involving Trelegy Ellipta at two doses and Relvar/Breo at two doses.

The primary endpoint was change in trough Forced Expiratory Volume in 1 second (FEV1) at 24 weeks, with a secondary endpoint of annual rate of moderate/severe asthma exacerbations. The trial showed a statistically significant lung function improvements for both Trelegy Ellipta dosage formulations compared with the corresponding Relvar/Breo treatments.

But the study failed to meet the secondary endpoint, showing a statistically insignificant 13% reduction in exacerbations. Adverse event rates were similar across all six arms, they said, with nasopharyngitis at 13% to 15%, headache at 5% to 9%, upper respiratory tract infection at 3% to 6% and bronchitis at 3% to 5%.

“We believe a once-daily single inhaler triple therapy that improves lung function is an advance for patients with uncontrolled asthma since this option is not currently available. We plan to submit these data for regulatory review after the full dataset is available,” GSK president & CSO Dr. Hal Barron said in prepared remarks.

“The Captain study has shown that triple therapy in a single inhaler provides a potential new treatment option for asthma management in patients uncontrolled on ICS/LABA,” added Innoviva respiratory medicine VP Paul Meunier.

The companies said full results from the trial are slated to be released at coming scientific meetings and via peer-reviewed journals.