GSK’s “ultra-long-acting” biologic depemokimab has demonstrated a significant reduction in severe asthma exacerbations over one year, according to late-stage results presented at the European Respiratory Society International Conference.
The duplicate phase 3 SWIFT-1 and SWIFT-2 trials have been evaluating the efficacy and safety of the candidate 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 alongside their standard-of-care treatment with medium- to high-dose inhaled corticosteroids and at least one more controller.
Both trials met their primary endpoints of significant reductions in the annualised rate of clinically significant exacerbations over 52 weeks versus placebo, with a pre-specified pooled analysis demonstrating a 54% reduction in exacerbations for depemokimab.
The pooled analysis also showed a 72% reduction in the secondary endpoint of clinically significant exacerbations requiring hospitalisation or an emergency department visit compared to placebo.
GSK added that despite showing improvements, the trials’ secondary endpoints assessing quality of life or the symptoms-based measure did not reach statistical significance versus placebo, but outlined that the data from the studies will continue to inform regulatory filings for depemokimab globally.
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 these patients, 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 at GSK, said the therapy “could offer physicians and millions of patients with severe asthma an option that provides reassurance of sustained suppression of a key marker of type 2 inflammation and a reduction in the rate of exacerbations and hospitalisation”.
An additional study is underway to assess depemokimab in severe asthma patients who are switched from GSK’s own Nucala (mepolizumab) or AstraZeneca’s Fasenra (benralizumab).