GSK Reports Positive Phase 3 Results for Long-Acting Asthma Biologic

GSK's innovative biologic treatment, depemokimab, has shown promising results in reducing severe asthma exacerbations over a year. This was revealed through late-stage findings presented at the European Respiratory Society International Conference. The phase 3 SWIFT-1 and SWIFT-2 trials were conducted to determine the safety and efficacy of this treatment in adults and adolescents with severe asthma characterized by type 2 inflammation, identified by blood eosinophil counts.

Participants in these studies were randomly assigned to receive either depemokimab or a placebo, in addition to their regular treatment regime. This regime included medium- to high-dose inhaled corticosteroids and at least one other controller medication. Both trials achieved their primary goal of significantly reducing the annualized rate of clinically significant asthma exacerbations over 52 weeks compared to the placebo. A pre-specified pooled analysis of the data showed that depemokimab led to a 54% reduction in these exacerbations.

The pooled analysis further indicated a 72% reduction in the number of clinically significant exacerbations that required hospitalization or emergency department visits when compared to the placebo group. Despite these improvements, secondary endpoints related to quality of life and symptom-based measures did not reach statistical significance when compared to placebo. However, GSK emphasized that the results will inform future regulatory filings for depemokimab worldwide.

In the UK alone, approximately 200,000 individuals suffer from severe asthma, a challenging form of the condition where symptoms are difficult to control. Over 80% of these cases are driven by type 2 inflammation. Depemokimab is designed for six-month dosing intervals and exhibits a high binding affinity and potency for interleukin-5, a crucial protein involved in type 2 inflammation, which drives severe asthma exacerbations.

Kaivan Khavandi, senior vice president and global head of respiratory/immunology research and development at GSK, stated that this therapy could offer physicians and millions of patients with severe asthma a treatment option that provides sustained suppression of a key marker of type 2 inflammation. This would lead to a reduction in the rate of asthma exacerbations and hospitalizations.

Furthermore, an additional study is currently being conducted to evaluate the effectiveness of depemokimab in severe asthma patients who are transitioning from GSK’s own Nucala (mepolizumab) or AstraZeneca’s Fasenra (benralizumab).

This breakthrough could significantly impact the management of severe asthma, offering a new and effective option for patients struggling with this chronic and debilitating condition. As research continues, depemokimab holds the potential to become a vital component of asthma treatment strategies globally.