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news.A phase lll study of GlaxoSmithKline's mepolizumab has met its co-primary endpoints and all secondary endpoints in patients with eosinophilic granulomatosis with polyangiitis (EGPA).
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EGPA is a rare disease in which patients suffer from inflammation that is widespread in the walls of small blood vessels.
The treatment aims is to induce and maintain remission and reduce the use of corticosteroids and other immunosuppressive therapies.
The co-primary endpoints for the 52-week study evalauted the entire remission duration and the proportion of patients in whom remission was maintained after treatment with mepolizumab compared to placebo treatment.
GSK said the duration of remission as defined by the proportion of patients achieving at least 24 weeks duration of remission, one of five pre-defined categories of duration, was 19/68 for mepolizumab and 2/68 for placebo.
As per the trial results, 22 patients subjected to mepolizumab, achieved remission at both weeks 36 and 48 while only two patients who were under placebo could achieve the same.
The phase III study also featured six secondary endpoints for investigating relapse, remission as well as use of corticosteroid. Patients had demonstrated significant differences for all of them as per statistics, favouring the IL-5 antagonist compared to placebo.
GSK vice president and mepolizumab medicine development lead Steve Yancey said: “We are very pleased to observe the positive benefits of treatment with mepolizumab across several clinically relevant measures in this first ever double-blind, placebo-controlled study in patients with Eosinophilic Granulomatosis with Polyangiitis.
“Given that patients with this rare systemic inflammatory disease have limited treatment options, these results represent a significant step forward in our efforts to help them. We now look forward to progressing our regulatory submission plans.”
Mepolizumab is yet to be approved by global regulators for treating EGPA. It is approved for use in the European Union, under the brand name Nucala, for use as an add-on treatment for severe refractory eosinophilic asthma in adult patients.
It is approved for use in the US as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.