UK-based pharmaceutical company GSK has announced results from two Phase III clinical trials of depemokimab in patients with severe asthma characterised by elevated blood eosinophil counts, a marker of type 2 inflammation.
The SWIFT-1 and SWIFT-2 trials are identical double-blind, placebo-controlled studies assessing the efficacy and safety of depemokimab as an adjunctive therapy versus placebo.
Both trials met their primary endpoints, demonstrating statistically significant decline in the annualised rate of clinically significant asthma exacerbations over 52 weeks compared with placebo.
In the pre-specified pooled analysis, the treatment was found to cause a 54% reduction in exacerbations.
Further analysis showed a 72% reduction in the secondary endpoint of exacerbations requiring hospitalisation or emergency department visits in the pooled data from both studies.
In the individual trials, secondary endpoints assessing quality of life or symptom-based measures showed improvements but did not reach statistical significance when compared with placebo.
Depemokimab's safety profile was comparable to that of the placebo, with similar proportions of patients experiencing adverse events (AEs) in both the depemokimab and placebo groups in SWIFT-1 and SWIFT-2.
No deaths or serious AEs were deemed to be related to the study treatment by the investigators.
GSK Respiratory/Immunology global head of research and development and senior vice-president Kaivan Khavandi said: “With a dosing schedule of just two injections per year, depemokimab has the potential to be the first approved ultra-long-acting biologic with six-month dosing.
“This 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 – the fundamental treatment goal in asthma.”
GSK recently reported that its asthma drug Nucala (mepolizumab) met the primary endpoint in a Phase III trial treating chronic obstructive pulmonary disease patients.
