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GlaxoSmithKline (GSK) Finally Starts Much-Anticipated Phase 3 Study For Rare Disease



2/14/2014 8:29:10 AM

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February 14, 2014 -- GlaxoSmithKline (GSK) today announced the start of a Phase III study to evaluate the efficacy and safety of mepolizumab, an investigational IL-5 antagonist, in patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA).

EGPA, previously known as Churg-Strauss syndrome, is a rare disease which is characterised by widespread inflammation in the walls of small blood vessels (vasculitis). It 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 disease can be life-threatening for some patients. A key goal in the treatment of EGPA is to induce and maintain remission while reducing the use of corticosteroids and other immunosuppressive therapies.

The pivotal Phase III study, MEA115921, is a randomised, double-blind study with the purpose to investigate the efficacy and safety of a 300mg dose of mepolizumab (administered subcutaneously every 4 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 study is being conducted as part of an agreement between GSK and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, demonstrating an example of industry – public body collaboration in the field of rare disease drug development.Through this collaboration the mechanisms that underlie EGPA will also be investigated, with potential future benefits for patients.

“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.” commented Richard Philipson, Disease Area Head, GSK Rare Diseases.“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.”

About Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss Syndrome)

EGPA is one of the rarest systemic vasculitic (inflammation of blood vessel walls) diseases with an approximate prevalence of 4,300 patients in the United States and five European countries, respectively. The mean age of diagnosis is 48 years. While symptoms vary from one patient to another, almost all have asthma and/or nasal sinus polyps and blood eosinophilia.

The current approach to disease management is primarily based on reduction of active inflammation and suppression of the immune response through the use of corticosteroid therapy with concomitant immunosuppressive therapy (e.g., methotrexate, azathioprine, mycophenolate mofetil) and/or cytotoxic agents (e.g., cyclophosphamide). Although the use of these treatments can be effective for establishing remission, patients remain vulnerable to either the complications of the long-term use of these therapies, or to the risk of relapse, particularly if the dose of corticosteroid is reduced.

About mepolizumab

Mepolizumab is an investigational fully humanised IgG monoclonal antibody specific for interleukin 5 (IL-5) which is in development for the following diseases: EGPA, severe asthma with eosinophilic inflammation, hypereosinophilic syndrome, eosinophilic esophagitis and nasal polyposis. The start of the Phase III programme investigating mepolizumab in patients with severe asthma with eosinophilic inflammation was announced in October 2012. Mepolizumab is not approved for use anywhere in the world.

IL-5 is a cytokine which regulates the growth, activation and survival of eosinophils (white blood cells) and provides an essential signal for the movement of eosinophils from the bone marrow into the lung and other organs. Mepolizumab binds to human IL-5, stopping it from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this manner reduces blood, tissue and sputum eosinophil levels, which in turn reduces eosinophil-mediated inflammation.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

GSK enquiries:

UK Media enquiries:

David Mawdsley

+44 (0) 20 8047 5502

(London)

Simon Steel

+44 (0) 20 8047 5502

(London)

David Daley

+44 (0) 20 8047 5502

(London)

Catherine Hartley

+44 (0) 20 8047 5502

(London)

US Media enquiries:

Stephen Rea

+1 215 751 4394

(Philadelphia)

Melinda Stubbee

+1 919 483 2510

(North Carolina)

Mary Anne Rhyne

+1 919 483 0492

(North Carolina)

Emily Beamer

+1 215 751 6622

(Philadelphia)

Jennifer Armstrong

+1 215 751 5664

(Philadelphia)

Analyst/Investor enquiries:

Sally Jackson

+44 (0) 20 8047 5543

(London)

Kirsty Collins (SRI CG)

+44 (0) 20 8047 5534

(London)

Tom Curry

+ 1 215 751 5419

(Philadelphia)

Gary Davies

+44 (0) 20 8047 5503

(London)

James Dodwell

+44 (0) 20 8047 2406

(London)

Jeff McLaughlin

+1 215 751 7002

(Philadelphia)

Ziba Shamsi

+44 (0) 20 8047 3289

(London)

Lucy Singah

+44 (0) 20 8047 2248

(London)

Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.

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