- GlaxoSmithKline's lung drug Trelegy could find new use as a treatment for uncontrolled asthma, posting on Thursday positive late-stage data which showed the triple combination inhaler helped improve lung function over another of the British pharma's respiratory drugs.
- Trelegy, which combines a steroid with two long-acting drugs in one inhaler, beat out GSK's Relvar/Breo on a measure of the amount of air a patient can exhale in one second, according to topline results from the CAPTAIN study.
- GSK has suffered heavily from entry of generic copies to its one-time top-selling respiratory drug Advair, making the success for Trelegy in asthma a small respite. Still, the drugmaker is counting on the triple therapy to help power its respiratory business moving forward.
As Advair's star has dimmed, GSK's HIV business has outshone its efforts in respiratory — long the pharma's calling card.
The period between January and March marked the first full quarter with Mylan's Advair (fluticasone/salmetrol) generic on the market. Sales tumbled accordingly, extending a yearslong slide brought about by growing market competition.
And in a further blow, GSK also reported a drop in revenues from its asthma biologic Nucala (mepolizumab) from last year's fourth quarter to the first three months of this year.
The success of Trelegy (fluticasone furoate/umeclidinium/vilanterol) in CAPTAIN, then, comes as some relief.
The Phase 3 study tested the triple inhaler against Relvar/Breo (fluticasone furoate/vilanterol) in 2,436 patients whose asthma was uncontrolled by maintenance medication.
Topline data showed patients on two dose regimens of Trelegy enjoyed a statistically significant improvement in lung function versus those on Relvar/Breo.
Results did not, however, show a significant difference in the annualized rate of moderate or severe attacks between the two study arms.
Adverse event rates were similar and the safety profile of Trelegy was consistent with prior clinical data, GSK said.
The pharma plans to submit the CAPTAIN results for regulatory review once the full dataset from the trial is available.
An expanded indication in uncontrolled asthma could provide a tailwind for Trelegy's sales. Currently approved for chronic obstructive pulmonary disorder, the drug posted 87 million pounds, or about $114 million, in first quarter revenue — a 13% jump from fourth quarter figures.
"The asthma opportunity could represent a doubling of the Trelegy opportunity, in our view," wrote analysts at Cantor Fitzgerald in a note to clients.
The drug may also see a boost from geographical expansion as well as label additions.
GSK is launching the drug in Japan and expects to win approval and begin sales in China this year as well.