GlaxoSmithKline (GSK) has announced positive results from a Phase III clinical trial evaluating its blockbuster drug Nucala (mepolizumab) for the treatment of chronic obstructive pulmonary disease (COPD). The MATINEE study, which followed patients for up to two years, demonstrated that Nucala, when added to inhaled maintenance therapy, led to a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations compared to placebo. This achievement marks a significant milestone for Nucala, meeting the study’s primary endpoint.
COPD is a respiratory condition affecting over 300 million people globally. Notably, around 40% of COPD patients exhibit type II inflammation, which is linked to an increased risk of exacerbations, characterized by worsening respiratory symptoms. IL-5, a key cytokine in type II inflammation, promotes the growth and activation of eosinophils, a type of white blood cell involved in the inflammatory response. Nucala, by targeting IL-5, aims to reduce this inflammatory process and alleviate COPD symptoms.
The positive results from the MATINEE study reinforce Nucala’s potential as a valuable treatment option for COPD patients. The drug is already approved in several countries for treating eosinophil-driven diseases such as severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis. GSK’s stock has seen a 17.8% rise this year, outperforming the industry’s performance, which has declined by 2.8%.
Nucala faces competition from other respiratory disease treatments. Regeneron and Sanofi’s Dupixent, an IL-4 and IL-13 inhibitor, received approval for treating COPD in patients with elevated blood eosinophils in the EU in July. This approval marked a significant achievement, making the European Medicines Agency the first regulatory authority worldwide to approve Dupixent for COPD. In the United States, the FDA is currently reviewing a supplemental biologics license application (sBLA) for Dupixent’s approval for COPD, with a decision expected on September 27. Dupixent is already approved for five type II inflammatory diseases, including severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, and prurigo nodularis.
Furthermore, Nucala also competes with AstraZeneca’s Fasenra, an IL-5 inhibitor similar to Nucala, which is approved for treating severe eosinophilic asthma. AstraZeneca is currently conducting late-stage studies to evaluate Fasenra’s effectiveness in treating COPD.
GSK’s strong performance in the respiratory disease market with Nucala underscores the company’s commitment to developing innovative therapies for patients with chronic respiratory conditions. The positive results from the MATINEE study are promising, paving the way for potentially expanding Nucala’s use in the treatment of COPD.
