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
Related Content
GSK shares results from phase 3 trial for gonorrhoea treatment
GSK has announced positive results from its phase 3 EAGLE-1 trial for gepotidacin, a potential …
GSK’s meningococcal vaccine candidate accepted for FDA review
GSK has announced that the US Food and Drug Administration (FDA) has accepted for review …
GSK shares data from phase 3 trial for Jemperli combinations for endometrial cancer treatment
GSK has announced positive results from part 1 and part 2 of its RUBY/ENGOT-EN6/GOG3031/NSGO phase …
