GSK’s Nucala meets Phase 3 goal in reducing hypereosinophilic syndrome flare-ups

pharmafile | November 13, 2019 | News story | Research and Development GSK, Nucala, pharma 

GlaxoSmithKline has unveiled new Phase 3 data for its IL-5 inhibitor Nucala (mepolizumab), revealing that the therapy met its primary endpoint in the treatment of the rare disease hypereosinophilic syndrome (HES).

In the trial, 50% fewer participants were shown to experience a flare-up of HES-related symptoms when treated with Nucala alongside standard of care as opposed to placebo plus standard of care over 32 weeks of treatment.

Additionally, Nucala patients exhibited a 66% lower risk of first HES flare-up compared to placebo, as well as a 66% reduction in the annualised rate of flare-ups.  On the back of the trial results, GSK asserted that Nucala was the first therapy to demonstrably reduce HES-related flare-ups. Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, remarked: “Mepolizumab has the potential to change the treatment landscape for patients with HES which is a complex and debilitating disease with limited therapeutic options today.”

Dr Gerald Gleich, an allergist, immunologist and HES expert at the University of Utah, also commented: “Mepolizumab is thought to work by reducing blood eosinophil levels and evidence suggests it has potential as a targeted treatment option for a range of inflammatory diseases driven by raised eosinophils. These data are very promising and should provide hope for patients affected by this rare, life-threatening condition caused by eosinophilic inflammation.”

GSK confirmed it would be submitting these data to regulatory bodies around the world in a bit to secure the first HES-related approvals for Nucala.

Matt Fellows

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