GSK plc (GSK) announced positive results from the MATINEE Phase 3 trial evaluating Nucala (mepolizumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults. Nucala, a monoclonal antibody targeting interleukin-5 (IL-5), showed significant promise in reducing the severity of COPD, a respiratory disease affecting over 300 million people globally.
The trial included COPD patients with various clinical presentations, including chronic bronchitis and/or emphysema. Participants were receiving optimized inhaled maintenance therapy and had evidence of type 2 inflammation characterized by elevated blood eosinophil counts. The study’s primary endpoint was met, demonstrating a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations in patients treated with Nucala compared to placebo. This positive outcome was observed over a treatment period of up to 104 weeks.
The preliminary safety profile of Nucala in the MATINEE trial aligns with its known safety profile. Further analysis of the data is currently ongoing. The full results of the MATINEE trial will be presented at a future scientific congress and will be used to inform ongoing discussions with regulatory authorities.
Nucala is already approved as an add-on, prescription maintenance treatment for patients aged six and older with severe eosinophilic asthma. However, it is not currently indicated for COPD anywhere in the world. In 2023, Nucala contributed 6% to GSK’s total sales, generating revenue of 1.65 billion pounds, representing an 18% year-over-year increase at constant exchange rates.
GSK’s announcement comes on the heels of the FDA’s approval of Verona Pharma plc’s VRNA Ohtuvayre (ensifentrine) for the maintenance treatment of COPD in adult patients. Ohtuvayre, the first inhaled product with a novel mechanism of action for COPD maintenance treatment in over 20 years, offers another potential treatment option for patients battling this disease.
The positive results from the MATINEE trial and the recent approval of Ohtuvayre signify progress in the development of new therapies for COPD, offering hope for better treatment options and improved outcomes for patients suffering from this prevalent respiratory disease.
