LeadSix-month dosing could simplify treatment to support millions of patients with severe...

Six-month dosing could simplify treatment to support millions of patients with severe asthma

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London, UK- 23 May 2024- GSK announced positive headline results from the phase III clinical trials SWIFT-1 and SWIFT-2, which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterised by blood eosinophil count. Both SWIFT-1 and SWIFT-2 met their primary endpoints of a reduction in the annualised rate of clinically significant exacerbations (asthma attacks) over 52 weeks. Patients treated with either depemokimab or placebo experienced similar overall incidence and severity of treatment-emergent adverse events across both trials. Further analysis of these data is ongoing.

Also read: GSK to become a founding partner of Fleming Initiative to fight AMR

Depemokimab is the first ultra-long-acting biologic to be evaluated in phase III trials with a binding affinity and high potency for interleukin-5 (IL-5), enabling six-month dosing intervals for patients with severe asthma. IL-5 is known to be a key cytokine (protein) in type 2 inflammation. This inflammation, typically identified by elevated blood eosinophil count, is the underlying pathology responsible for more than 80% of people with severe asthma and can lead to unpredictable exacerbations.

Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, said: “These results add to the established body of evidence that targeted inhibition of IL-5 plays a key role in reducing type 2 inflammation that drives severe asthma exacerbations. Depemokimab could offer the possibility of sustained inhibition of this pathway, 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.”

Expertise in respiratory diseases and the science of IL-5 has informed the ongoing evidence generation program evaluating the impact of six-month dosing of sustained IL-5 inhibition in patients achieving clinical remission in severe asthma.5 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 worldwide.

Depemokimab is currently not approved anywhere in the world.

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