GSK has announced positive data from two Phase III trials of its asthma candidate depemokimab.

The pharma giant announced the drug met primary endpoints in both the SWIFT-1 (NCT04719832) and SWIFT-2 (NCT4718103) trials of a reduction in exacerbations (asthma attacks) over 52 weeks.

The two randomised, multi-centre, placebo-controlled trials investigated depemokimab in adults and adolescents with severe asthma with type 2 inflammation characterised by blood eosinophil count.

The trials enrolled 375 and 380 participants who received the drug or placebo in addition to their standard of care treatment with medium to high-dose inhaled corticosteroids (ICS) plus at least one additional controller.

Another Phase III trial, NIMBLE, is investigating the efficacy and safety of depemokimab when patients with severe asthma are switched from mepolizumab or benralizumab.

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.

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IL-5 is known to be a key cytokine (protein) in type 2 inflammation which is identified as the underlying pathology responsible for more than 80% of people with severe asthma.

Currently, all marketed IL-5 therapies are dosed once monthly. As a result, depemokimab’s twice-yearly dosing schedule will have lots of benefits for patients including improved adherence.

According to Research Partnership Quant, 73% of physicians believe longer dosing intervals would be beneficial to patients.

GSK is hoping to receive a regulatory decision on depemokimab next year.

Depemokimab is also being investigated in eosinophilic granulomatosis with polyangiitis (EGPA), chronic rhinosinusitis with nasal polyps (CRSwNP) and hypereosinophilic syndrome (HES).

Asthma landscape

Severe uncontrolled asthma is associated with increased mortality and morbidity, diminished quality of life, and increased health expenditures. Despite there being several biological therapies approved in the past few years, there have been no new oral therapies marketed since the late 1990s.

A report by GlobalData says that GSK is a key player in the disease space with four key products for asthma – Breo Ellipta, Nucala, Advair Diskus, and Trelegy Ellipta. Other major players include AstraZeneca, Boehringer Ingelheim and Roche.

GlobalData is the parent company of the Clinical Trials Arena.