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GSK Reports Successful Phase III Trials for Severe Asthma Treatment Depemokimab | iPharmaCenter

GSK has announced encouraging results from its phase III trials, SWIFT-1 and SWIFT-2, testing the effectiveness and safety of depemokimab in treating severe asthma. Both studies achieved their main goals, demonstrating significant and meaningful reductions in asthma exacerbations over a year compared to a placebo.

Depemokimab stands out as a potential game-changer, being the first ultra-long-acting biologic for severe asthma with a dosing schedule of once every six months. This extended dosing interval could simplify treatment for millions of patients.

The SWIFT-1 and SWIFT-2 trials focused on adults and adolescents with severe asthma characterized by type 2 inflammation, indicated by high blood eosinophil counts. Both trials showed that patients receiving depemokimab experienced fewer clinically significant exacerbations over 52 weeks compared to those receiving a placebo. The incidence and severity of adverse events were comparable between the depemokimab and placebo groups, and further data analysis is ongoing.

Depemokimab is unique for its long-acting nature and high affinity for interleukin-5 (IL-5), allowing for six-month dosing intervals. IL-5 is a critical protein in type 2 inflammation, which is marked by elevated eosinophil levels and affects over 80% of individuals with severe asthma, leading to unpredictable exacerbations.

GSK's extensive research in respiratory diseases and IL-5 biology has driven the development of this treatment, aiming to provide long-term remission for severe asthma patients. Detailed results from the SWIFT-1 and SWIFT-2 trials will be shared at an upcoming scientific conference and will support global regulatory submissions.

The phase III clinical program includes SWIFT-1, SWIFT-2, and an open-label extension study called AGILE.

Both SWIFT trials were 52-week, randomized, double-blind, placebo-controlled studies conducted across multiple centers. They involved 375 and 380 participants, respectively, who received either depemokimab or a placebo alongside their standard treatment regimen, which included medium to high-dose inhaled corticosteroids and at least one additional controller.

Another study, NIMBLE, is currently evaluating the safety and efficacy of transitioning severe asthma patients from existing treatments like mepolizumab or benralizumab to depemokimab.

With its prolonged half-life, depemokimab promises sustained inhibition of inflammatory processes and is being tested for various type 2 inflammatory conditions. Ongoing phase III trials are also investigating its use in eosinophilic granulomatosis with polyangiitis (EGPA), chronic rhinosinusitis with nasal polyps (CRSwNP), and hypereosinophilic syndrome (HES).

Severe asthma is defined by the necessity of high-dose inhaled corticosteroids combined with a second controller or biologic therapy to maintain control, or as asthma that remains uncontrolled despite such treatments. Over 80% of severe asthma cases are driven by type 2 inflammation, which is characterized by high eosinophil levels detectable through a blood test. IL-5 plays a crucial role in this process, promoting the growth, activation, and survival of eosinophils, and is a central target in managing type 2 inflammatory diseases.


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