GSK starts rare blood trial
pharmafile | February 18, 2014 | News story | Research and Development, Sales and Marketing | GSK, blood, mepolizumab
GlaxoSmithKline has begun a Phase III study to look at mepolizumab in a rare condition characterised by vasculitis – widespread inflammation in the walls of small blood vessels.
The safety and efficacy of the investigational interleukin 5 (IL-5) antagonist will be examined in patients with eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome.
IL-5 regulates the way white blood cells (eosinophils) develop, making a signal for them to move from bone marrow into other organs – and mepolizumab works by binding to human IL-5 and in turn stopping it from binding to its receptor on the surface of eosinophils.
EGPA can be life-threatening, as it has the potential to affect the heart, lungs, skin, gastrointestinal tract, kidneys and nervous system.
It is one of the rarest systemic vasculitic diseases, affecting only a few thousand patients in the US and Europe: the mean age of diagnosis is 48 years and symptoms vary, although almost all patients have asthma, nasal sinus polyps and blood eosinophilia.
GSK is collaborating on the study with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health.
“This is the first ever double-blind, placebo-controlled study to be conducted in patients with EGPA, marking a significant milestone in our efforts to help patients with this rare systemic inflammatory disease,” said Richard Philipson, disease area head, GSK Rare Diseases.
There are limited treatment options for patients and the tie-up with NIAID will help research in this therapy area by examining the mechanisms that underlie the condition.
GSK hopes that mepolizumab can induce and maintain remission while reducing the use of corticosteroids and other immunosuppressive therapies – such as methotrexate or azathioprine – currently used to manage the disease.
The MEA115921 study will see a 300mg dose of subcutaneous mepolizumab administered every four weeks, compared with placebo, over 52 weeks in patients with relapsing or refractory EGPA who are receiving standard of care.
Mepolizumab is also in development for severe asthma with eosinophilic inflammation, hypereosinophilic syndrome, eosinophilic esophagitis and nasal polyposis.
Adam Hill
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