Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

GSK declares SWIFT-1 & SWIFT-2 phase III trials of depemokimab in patients with severe asthma meets primary endpoints

GSK plc reported positive outcomes from phase III trials SWIFT-1 and SWIFT-2, evaluating depemokimab's efficacy and safety in severe asthma with type 2 inflammation. Both trials met primary endpoints, showing reduced annualized asthma exacerbations over 52 weeks. Treatment-emergent adverse events were similar between depemokimab and placebo groups. Depemokimab, an ultra-long-acting biologic, targets interleukin-5 (IL-5), crucial in type 2 inflammation, offering six-month dosing intervals. IL-5 drives exacerbations in over 80% of severe asthma cases.

Unapproved globally, depemokimab's phase III program includes SWIFT-1 and SWIFT-2, replicate 52-week trials with 375 and 380 participants respectively, receiving depemokimab or placebo alongside standard treatment.

An ongoing study, NIMBLE, explores depemokimab's efficacy when switching from mepolizumab or benralizumab. Depemokimab's extended half-life inhibits broad inflammation, under investigation in various conditions. Severe asthma, often requiring high-dose corticosteroids or biologics, stems from type 2 inflammation, marked by elevated eosinophils. IL-5, along with IL-4 and IL-13, drives pathology in immune-mediated conditions, regulating eosinophil functions.