The Phase 3 study of GlaxoSmithKline plc (ADR) (NYSE:GSK) Mepolizumab, for use in patients who are suffering from severe hypereosinophilic syndrome (HES), has begun. Between 80 and 120 participants will be chosen for the study to evaluate the effectiveness of Mepolizumab in comparison with placebo.
During the 32 weeks that the study will be conducted, the primary endpoint will be finding out the percentage of patients whose HES symptoms worsen and will require therapy to be escalated. The secondary endpoints of the study will be to demonstrate the efficacy of Mepolizumab in comparison with a placebo and to find out how long it takes before the first HES flare as well the percentage of patients whose symptoms of HES worsen between the 20th week and the 32nd week.
Eosinophil overproduction
Around 20,000 people around the world suffer from HES inflammatory disorders and the condition is characterised by an overproduction of eosinophil, a kind of white blood cell. When these eosinophils are activated, they can infiltrate various tissues causing organ damage and inflammation which will affect daily functions. The kind of complications that arise depends on the organs that are affected. These conditions range from cardiac and respiratory problems to blood abnormalities to malaise and fever. When left untreated, these symptoms can get worse and can at some point cause death.
“The goal of HES treatment is to prevent excessive production of eosinophils,” said Mepolizumab’s Medicine Development Leader and vice president Steve Yancey.
Safety and efficacy
In the course of the Phase III study, participants who will not be on the placebo will be offered 300mg of Mepolizumab in a period of every four weeks. Participants in the study will be adult patients and adolescent patients. Besides the efficacy of Mepolizumab, its safety will also be tested.
In the European Union and the United States, Mepolizumab has received orphan drug status. Nucala is the brand name under which the regulatory authorities in both territories have approved it as an add-on drug for the treatment of patients suffering from severe asthma which is characterised by an eosinophilic phenotype.
On Friday shares of GlaxoSmithKline plc fell by 0.75% to close the day at $42.16.
