Amgen and AstraZeneca's Tezspire Shows Promise in Treating COPD
On May 16-21, at the ATS International Conference, Amgen and AstraZeneca released data from the Phase IIb COURSE trial for their TSLP-inhibiting monoclonal antibody, Tezspire. Despite missing the primary endpoint of reducing annual moderate to severe COPD exacerbations, the therapy demonstrated a 48% reduction in severe exacerbations among patients with high eosinophil levels. Tezspire, which gained approval for severe asthma in 2021, may emerge as a competitor to Sanofi and Regeneron's Dupixent in the treatment of COPD, pending the FDA's decision on Dupixent's use in COPD by June.
Key Takeaways
- Tezspire missed the primary endpoint in a Phase IIb COPD trial, but displayed potential in a subgroup of patients with high eosinophil levels.
- Patients with BEC of 150 cells/μL or more experienced a 37% reduction in moderate or severe exacerbations with Tezspire compared to the placebo.
- In the subgroup analysis, Tezspire also demonstrated a 48% reduction in severe exacerbations compared to the placebo.
- Based on promising subgroup results, Amgen and AstraZeneca are planning Phase III trials for Tezspire in COPD.
- Sanofi and Regeneron's Dupixent, Tezspire's primary competitor in the COPD space, exhibited a 34% reduction in moderate or severe acute COPD exacerbations in a Phase III trial.
Analysis
While the failure to meet the primary endpoint is disappointing for Amgen and AstraZeneca, the significant reduction in COPD exacerbations among patients with high eosinophil levels provides a ray of hope. This development could influence Sanofi and Regeneron's market position, with Tezspire potentially emerging as a competitor to Dupixent in COPD treatment. The upcoming FDA decision on Dupixent's use in COPD will be pivotal in shaping this competition, influencing short-term pharmaceutical and investment landscapes. The long-term implications include the potential for more targeted COPD treatments, potentially benefiting patients and healthcare systems.
Did You Know?
- TSLP-inhibiting monoclonal antibody: Tezspire is a type of monoclonal antibody designed to block the activity of thymic stromal lymphopoietin (TSLP), a protein crucial in the inflammatory response associated with COPD and severe asthma.
- COPD exacerbations: These signify sudden worsening of COPD symptoms due to triggers like infections or air pollution, often leading to hospitalization and a significant decline in quality of life.
- Eosinophils and BEC: High eosinophil levels in the blood or lungs are linked to increased inflammation and adverse outcomes in COPD and asthma. The positive response to Tezspire treatment in patients with high eosinophil levels suggests its potential efficacy in managing elevated airway inflammation.