GSK's (GSK.US) "first-in-class" antibody therapy Nucala met the primary endpoint in its Phase 3 trial

GlaxoSmithKline (GSK.US) announced positive results from its Phase 3 MATINEE clinical trial of Nucala (mepolizumab), a "first-in-class" antibody therapy, in patients with chronic obstructive pulmonary disease (COPD). The trial results will support GSK's discussions with regulators to submit an application for the extension of Nucala's indication.

The MATINEE trial met its primary endpoint, with Nucala added to an inhaled maintenance therapy, significantly reducing the annual rate of moderate/severe disease exacerbations compared to placebo, with a clinically meaningful difference.

Nucala was first approved in the US in 2015 for the treatment of severe asthma with an eosinophilic phenotype. It is a monoclonal antibody targeting IL-5, developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation.