GSK Begins Phase III Trial To Evaluate Rare Disease Drug Mepolizumab
GlaxoSmithKline announced it has started Phase III trials for mepolizumab in patients with the rare disease Eosinophilic Granulomatosis with Polyangiitis (EGPA). EGPA is a rare disease characterized by widespread vasculitis. It can affect multiple organs including the nervous system, the heart, lungs, skin, kidneys, and the gastrointestinal tract. EGPA causes varying symptoms based on what organs affected and to what extent. The rare disease can be fatal for some patients. EGPA is also previously known as Churg-Strauss syndrome.
Treatments for EGPA usually focus on inducing and maintaining remission, while reducing use of corticosteroids and other immunosuppressive therapies.
Mepolizumab is an investigational fully humanized lgG monoclonal antibody which specifically antagonizes interleukin 5 (IL-5). IL-5 is a cytokine which regulates the growth activation and survival of eosinophils. By binding to IL-5, the drug stops it from binding to its receptor and reduces blood, tissue, and sputum eosinophil levels, which in turn reduce eosinophil-mediated inflammation present in EGPA.
The drug will be investigated in the Phase III study MEA115921. The purpose of the randomized, double blind study is to establish the efficacy and safety of a 300mg dose of mepolizumab. The drug is to be administered subcutaneously every four weeks against a placebo over a 52-week study treatment period in patients with relapsing or refractory EGPA receiving standard therapy including background corticosteroid therapy with or without immunosuppressive therapy. MEA115921 will be conducted by GSK in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health. GSK said the partnership is an example of public body collaboration in the field or rare disease drug development.
Richard Philipson, Disease Area Head, GSK Rare Diseases, 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 our 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. ”