▎WuXiEdited by Kant Content Team

GSK announced positive results from its two pivotal Phase 3 clinical trials, SWIFT-1 and SWIFT-2, today. The analysis showed that GSK's investigational monoclonal antibody depemokimab met the primary endpoints in both trials, effectively reducing the frequency of asthma attacks in adult and adolescent patients with severe asthma characterized by Type 2 inflammation (marked by blood eosinophil count). According to the press release,Depemokimab may become the first approved ultra-long-acting biologic that requires dosing only once every six months for the treatment of severe asthma.

Severe asthma refers to asthma that requires treatment with high-dose inhaled corticosteroids plus a second controller (and/or systemic corticosteroids) or biologics to prevent it from becoming "uncontrolled," or which remains "uncontrolled" despite therapy.

SWIFT-1 and SWIFT-2 are two identically designed, randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 clinical trials, with 375 and 380 patients enrolled respectively, lasting 52 weeks. These two trials aim to evaluate the efficacy and safety of depemokimab as an adjunctive treatment. Enrolled patients were randomly assigned to receive either depemokimab or placebo, in addition to standard care treatment consisting of medium- to high-dose inhaled corticosteroids and at least one additional controller.

The analysis shows,SWIFT-1 and SWIFT-2 both met their primary endpoints, demonstrating a statistically significant reduction in the annualized rate of clinically significant worsening (asthma exacerbations) in patients compared to placebo over 52 weeks.In two trials, the overall incidence and severity of treatment-emergent adverse events were similar in patients receiving depemokimab or placebo.

According to the press release,dEpemokimab is the first to be evaluated in a Phase 3 trialInterleukin-5 (IL-5) TargetingUltra-long-acting biologics.Depemokimab can bind to IL-5 with high affinity and is administered once every six months for the treatment of severe asthma patients.IL-5 is a key cytokine in type 2 inflammation. More than 80% of severe asthma cases are driven by type 2 inflammation, characterized by elevated eosinophil levels and unpredictable exacerbations.