Phase 3 trials for depemokimab look promising, following completion of SWIFT-1 and SWIFT-2 clinical trials. Manufactured by GSK, the drug has the potential to be the first approved ultra-long-acting biologic with a six-month dosing schedule for severe asthma. That timing could simplify treatment for millions of patients with the respiratory condition.
Depemokimab features a binding affinity and high potency for interleukin-5 (IL-5), a key cytokine (protein) in type 2 inflammation. Both trials assessed the drug’s efficacy and safety in adults and adolescents diagnosed with severe asthma with type 2 inflammation.
“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,” said Kaivan Khavandi, PhD, MBA, senior vice president of respiratory and immunology, R&D at GSK.
The 52-week trial studied 375 and 380 participants, respectively, who used medium- to high-dose inhaled corticosteroids and at least one additional controller. Researchers assessed patient blood eosinophil counts, which is the underlying pathology responsible for more than 80% of people with severe asthma and can cause unpredictable exacerbations.
An additional study (NIMBLE) is underway to assess the efficacy and safety of depemokimab when participants with severe asthma are transitioned from mepolizumab or benralizumab. The drug is currently being evaluated in phase 3 trials across other IL-5 mediated diseases, including eosinophilic granulomatosis with polyangiitis (EGPA), chronic rhinosinusitis with nasal polyps (CRSwNP) and hypereosinophilic syndrome (HES). Depemokimab is currently not approved anywhere in the world.
