GSK antibody drug lessens COPD attacks in trial

GSK announced on Friday that its drug, Nucala, achieved positive results in a Phase 3 clinical trial involving patients with chronic obstructive pulmonary disease (COPD). The trial, named MATINEE, focused on COPD patients with chronic bronchitis and/or emphysema who were already undergoing inhaled therapy and exhibited signs of a specific type of inflammation. The addition of Nucala to these patients' treatment plans significantly reduced the frequency of disease exacerbations when compared to a placebo, according to GSK.

The study monitored patients' progress over a period extending up to two years. While GSK did not provide detailed safety or efficacy data, it mentioned that the preliminary side effect profile was consistent with previous studies conducted on Nucala.

GSK's renewed efforts come after an initial setback in 2018 when the Food and Drug Administration (FDA) denied approval for Nucala's use in treating COPD. At that time, the FDA requested additional clinical data to substantiate the expanded use of the drug. Nucala, a biologic therapy targeting the interleukin-5 protein, originally gained approval in 2015 for treating severe asthma. GSK believes Nucala could potentially treat a variety of inflammatory conditions, including COPD.

GSK stated that the new data would play a crucial role in ongoing discussions with regulatory authorities. The company also intends to present the study's findings at an upcoming medical conference.

Meanwhile, French pharmaceutical company Sanofi and its partner Regeneron Pharmaceuticals are also vying to introduce a new treatment for COPD. Their drug, Dupixent, demonstrated positive outcomes in two late-stage trials last year. The companies are awaiting a decision from the FDA on their application for expanded approval of Dupixent, expected by September 27, following a three-month delay.

COPD affects over 300 million people globally, with approximately 40% exhibiting the type of inflammation targeted in GSK's recent trial. The disease can lead to severe lung damage, resulting in hospitalizations and an increased risk of mortality.

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