GlaxoSmithKline (GSK) has dosed the first patient in a Phase III trial investigating its long-acting anti-IL-5 monoclonal antibody for the treatment of severe eosinophilic asthma (SEA).
The SWIFT-2 trial is part of a Phase III clinical programme evaluating the safety and efficacy of GSK3511294 (GSK’294), an investigational biologic designed to deliver long-acting suppression of IL-5 in patients with SEA from one injection every six months.
IL-5 is a key cytokine responsible for the proliferation, activation and survival of eosinophils, which plays a role in over 50% of patients with severe asthma, making it a proven target for treatment, according to GSK.
The Phase III programme for GSK’294 involves three studies and 2,450 patients to assess the efficacy and safety of the anti-IL-5 treatment.
The SWIFT-1 and SWIFT-2 trial will assess GSK'294 in participants with severe uncontrolled asthma with an eosinophilic phenotype, despite standard of care treatment with medium to high dose inhaled corticosteroids as well as one additional controller.
Another study – NIMBLE – will assess whether patients with severe asthma with an eosinophilic phenotype, who are benefitting from mepolizumab or benralizumab treatment, can maintain that benefit when transitioned to GSK’294 treatment.
“Around 10% of all asthma patients suffer from the avoidable symptoms of severe eosinophilic asthma and only one in four patients who are eligible for a biologic therapy currently receive one,” said Christopher Corsico, senior vice president development, GSK.
"These patients might benefit from more targeted therapies to better control their condition. We believe GSK’294 could provide another option to these patients that build on the positive impact seen with current anti-IL5 treatments and may also offer the advantage of one subcutaneous injection every six months," he added.