GSK starts the first phase 3 study with a long-acting anti-IL-5 treatment for patients with severe asthma
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the first patient has been dosed in the SWIFT-2 trial as part of the phase 3 clinical programme investigating the safety and efficacy of GSK3511294 (?GSK?294?) in severe eosinophilic asthma (SEA).
GSK?294 is an investigational medicine with potential to be the first biologic to deliver long-acting suppression of IL-5 in patients with SEA from one subcutaneous injection every six months.
Christopher Corsico, Senior Vice President Development, GSK, said:??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. 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.?
GSK?294 is an anti-IL-5 monoclonal antibody currently in development for the treatment of severe eosinophilic asthma. It is a distinct, new biologic entity and has been engineered for high affinity and long-acting suppression of IL-5 function. IL-5 is the major cytokine responsible for the proliferation, activation and survival of eosinophils, making it a proven treatment target for severe asthma patients with higher levels of eosinophils. In patients with severe eosinophilic asthma, targeted anti-IL-5 therapies are a well-established and effective treatment approach.
GSK?294 has progressed from phase 1 to phase 3 studies in three and a half years. The planned phase 3 programme, which involves three studies and 2,450 patients, will assess the efficacy and safety of GSK?294.
- SWIFT 1?(N=375) and?SWIFT 2?(N=375) will assess the efficacy and safety of GSK?294 in participants with severe uncontrolled asthma with an eosinophilic phenotype despite standard of care treatment with medium to high dose inhaled corticosteroids plus at least one additional controller.
- NIMBLE?(N=1700 patients) will assess whether participants with severe asthma with an eosinophilic phenotype, who are currently benefitting from mepolizumab or benralizumab treatment can maintain treatment benefit when switched to GSK?294. Throughout the study, all participants will continue their non-biologic baseline standard of care asthma treatment.