GlaxoSmithKline (NYSE:GSK) announces positive results from a Phase 3 clinical trial evaluating Nucala (mepolizumab) in patients with a rare inherited condition called hypereosinophilic syndrome (HES).
The trial met the primary endpoint of a statistically significantly lower proportion of patients in the treatment group [Nucala + standard-of-care (SOC) therapy] experiencing an HES flare over the 32-week study period compared to placebo + SOC (28% vs. 56%; p=0.002).
The risk of an HES flare was 66% lower in the Nucala cohort compared to control (hazard ratio = 0.34).
No new safety signals were reported.
HES, affecting ~20K people globally, is characterized by the chronic overproduction of a type of white blood cell called eosinophils which leads to inflammation and organ damage.
The company plans to file marketing applications in 2020.
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