The first patient has been injected with GSK3511294 (GSK’294) as part of GlaxoSmithKline’s (GSK) SWIFT-2 Phase III trial for severe eosinophilic asthma (SEA).
GSK’294 has advanced from Phase II to Phase III studies in three and a half years. The current Phase III programme for the drug candidate involves three studies and 2,450 patients and will assess the efficacy and safety of GSK’294.
GSK’294 is an investigational biologic drug with the potential to deliver long-acting suppression of interleukin 5 (IL-5) in patients with SEA from one subcutaneous injection administered every six months.
IL-5 is the major cytokine accountable for the reproduction, activation and survival of eosinophils, playing a role in over 50% of patients with severe asthma. This makes it a prime target for treating patients with severe asthma and increased levels of eosinophils, said GSK.
“In patients suffering from severe eosinophilic asthma, targeted anti-IL-5 therapies are a well-established and effective treatment approach,” the company said
The SWIFT-1 and SWIFT-2 trials will assess the efficacy and safety of GSK’294 in patients with severe uncontrolled asthma with an eosinophilic phenotype despite standard-of-care treatment with medium to high-dose inhaled corticosteroids plus at least one additional controller.
Another study, named NIMBLE, will evaluate whether participants with severe eosonophilic asthma, who are currently benefitting from mepolizumab or benralizumab treatment, can maintain treatment benefit when switched to GSK’294. Throughout the study, all participants will continue their non-biologic baseline standard-of-care asthma treatment.
“Around 10% of all asthma patients suffer from the avoidable symptoms of severe eosinophilic asthma and only one in four patients who are eligible for a biologic therapy currently receive one,” said GSK’s senior vice president of development Christopher Corsico.
“These patients might benefit from more targeted therapies to better control their condition. We believe GSK’294 could provide another option to these patients that builds on the positive impact seen with current anti-IL5 treatments and may also offer the advantage of one subcutaneous injection every six months.”
Patients suffering from severe asthma have limited options for managing the condition and those currently available require the patient to take daily medications, often multiple times a day.
Those with severe asthma are defined by their need for treatment with medium or high-dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent the condition from becoming uncontrolled. Some patients’ symptoms remain uncontrolled despite this therapy. Severe sufferers of asthma are also often categorised by long-term use of oral corticosteroids (OCS).