Advertisement GlaxoSmithKline starts Phase lll trial of mepolizumab in EGPA patients - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

GlaxoSmithKline starts Phase lll trial of mepolizumab in EGPA patients

UK-based drug manufacturer GlaxoSmithKline (GSK) has started a Phase III trial to evaluate the efficacy and safety of an investigational IL-5 antagonist 'mepolizumab' in patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA).

GSK headquarters

EGPA, which can be life-threatening for some patients, is previously known as Churg-Strauss syndrome and it is a rare disease which is characterized by widespread inflammation in the walls of small blood vessels (vasculitis).

The disease can affect multiple organs, including the heart, lungs, skin, gastrointestinal tract, kidneys, and nervous system, with varying symptoms, depending on which organs are affected, and to what extent.

The main aim in the treatment of EGPA is to induce and maintain remission while reducing the use of corticosteroids and other immunosuppressive therapies.

The Phase III trial, MEA115921, is a randomized, double-blind study designed to assess the efficacy and safety of a 300mg dose of mepolizumab given every four weeks compared with placebo over a 52-week study treatment period in patients with relapsing or refractory EGPA receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy.

The trial is being conducted as part of an agreement between GSK and the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), through which the mechanisms that underlie EGPA will also be investigated, with potential future benefits for patients.

GSK disease area head Richard Philipson said this is the first ever double-blind, placebo-controlled study to be conducted in patients with Eosinophilic Granulomatosis with Polyangiitis marking a significant milestone in the company’s efforts to help patients with this rare systemic inflammatory disease.

"There are currently limited treatment options for patients with EGPA and our plan to start this Phase III study was achieved in collaboration with the NIAID," Philipson added.


Image: GSK House, the world headquarters of GlaxoSmithKline in Brentford, London. Photo: courtesy of Maxwell Hamilton.