GSK has shared positive headline results from two late-stage studies of its “ultra-long-acting” biologic, depemokimab, in patients with severe asthma.
The phase 3 SWIFT-1 and SWIFT-2 trials have been evaluating the efficacy and safety of the investigational biologic in adults and adolescents with severe cases of the lung condition and type 2 inflammation characterised by blood eosinophil count.
Patients were randomised to receive depemokimab or placebo, in addition to their standard-of-care treatment with medium- to high-dose inhaled corticosteroids and at least one more controller.
Both studies met their primary endpoints of a reduction in the annualised rate of clinically significant exacerbations over 52 weeks for patients receiving depemokimab compared to placebo, GSK said.
The company added that the overall incidence and severity of treatment-emergent adverse events were similar in patients treated with either depemokimab or placebo across both trials.
Approximately 200,000 people in the UK have severe asthma, a form of asthma where symptoms are harder to control. In more than 80% of patients with severe asthma, their condition is driven by type 2 inflammation.
Depemokimab, designed to allow for six-month dosing intervals, has a binding affinity and high potency for interleukin-5, a key protein in the type 2 inflammation that drives severe asthma exacerbations.
Kaivan Khavandi, senior vice president, global head of respiratory/immunology research and development, said: “Depemokimab could offer the possibility of sustained inhibition of [interleukin-5], with a dosing schedule of just two injections per year.
“This is important, as research shows that 73% of physicians believe longer dosing intervals would be beneficial to patients who are often juggling multiple therapies.”
The full results of SWIFT-1 and SWIFT-2 will be presented at an upcoming scientific congress and will be used to support regulatory submissions to health authorities globally, GSK outlined.
An additional study is underway to assess depemokimab in severe asthma patients who are switched from mepolizumab or benralizumab.
The drug is also currently being evaluated in phase 3 trials across a range of other interleukin-5-mediated diseases, including eosinophilic granulomatosis with polyangiitis, chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome.