GSK's Nucala reduces COPD exacerbations in Phase 3 trial, but data undisclosed

GSK's drug Nucala has successfully completed a critical late-phase clinical trial for chronic obstructive pulmonary disease (COPD), potentially positioning it as a significant player against emerging treatments that aim to revolutionize COPD management. Currently approved for severe asthma and chronic rhinosinusitis, Nucala's potential label expansion to include COPD could dramatically increase its market reach, considering over 300 million people worldwide are diagnosed with this lung disease.

In the Phase 3 MATINEE trial, which was placebo-controlled, Nucala, an anti-IL-5 monoclonal antibody, was administered alongside standard inhaled maintenance therapy. The primary endpoint of the study was achieved, demonstrating a statistically significant reduction in the annual rate of moderate to severe exacerbations in COPD patients over a period of up to 104 weeks. Participants included in the trial had experienced at least two moderate exacerbations or one severe exacerbation in the year before screening, coupled with evidence of type 2 inflammation, indicated by elevated blood eosinophil levels.

While GSK has not yet disclosed specific numerical results, the company plans to present detailed findings at an upcoming scientific conference and share the data with regulatory authorities as part of their ongoing discussions.

Last month, analysts from TD Cowen highlighted that Sanofi and Regeneron's dual IL-4/IL-13 blocker, Dupixent, had set a benchmark for success in COPD treatment. In their Phase 3 NOTUS trial, Dupixent, combined with standard care, reduced exacerbations by 34% compared to placebo. The FDA is slated to make a decision on Dupixent's approval by September 27, following an extension of the original review date.

Nucala first received FDA approval in 2015 for severe asthma and has since expanded its indications to include chronic rhinosinusitis and hypereosinophilic syndrome, among others. Its sales rose by 17% in the second quarter, reaching £482 million ($634.7 million) compared to the same period in 2023.

Should Nucala gain approval for COPD, it won't stand alone in the market. Recently, the FDA approved Verona Pharma's ensifentrine in June, marking the first new maintenance treatment for COPD with a unique mechanism in over 20 years. Ensifentrine works by targeting PDE3 and PDE4 enzymes.

Additionally, AstraZeneca and Amgen are developing their own COPD treatment, Tezspire, a monoclonal antibody targeting TSLP. Further down the pipeline, Uniquity Bio is advancing a former Merck candidate named solrikitug, which has recently moved into Phase 2 development.

The results of the MATINEE trial place Nucala in a promising position as GSK continues to explore ways to enhance its therapeutic arsenal for respiratory conditions. The forthcoming data releases and regulatory consultations will be crucial in determining its future impact on the COPD market.

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