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Tezspire® Reveals Promise for COPD Patients: New Findings Unveiled at ATS 2024

NextEdge Admin

20 May 2024

3 min 23 sec

Amgen and AstraZeneca disclosed the outcomes of the Phase 2a COURSE trial assessing Tezspire® (tezepelumab-ekko) in individuals with moderate to very severe chronic obstructive pulmonary disease (COPD), irrespective of their baseline blood eosinophil counts (BEC), emphysema, chronic bronchitis, or smoking history. Although the primary results did not achieve statistical significance, with a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52, notable improvements were observed in certain patient subgroups.

Significantly, among patients with BEC ≥150 cells/µL, tezepelumab exhibited a nominally significant 37% reduction in the rate of moderate or severe exacerbations compared to placebo. This subset represents approximately 65% of bio-eligible COPD patients. Moreover, in patients with BEC ≥300 cells/µL, tezepelumab demonstrated a numerical reduction of 46% in exacerbation rates. Trends toward enhanced outcomes were also noted for pre-bronchodilator forced expiratory volume (FEV1) and St. George’s Respiratory Questionnaire (SGRQ) total score.

Dr. Jay Bradner, Amgen’s executive vice president of Research and Development, highlighted the persistent need for effective COPD therapies, especially for patients with elevated eosinophil counts. Plans are underway for a Phase 3 clinical program to further evaluate tezepelumab in COPD.

Subgroup analysis of the COURSE trial underscored tezepelumab’s potential, revealing improvements in lung function (FEV1) and quality of life (SGRQ score) across different eosinophil count thresholds. The safety profile remained consistent with its approved use in severe asthma, with the most common adverse events being worsening of COPD and incidents of COVID-19 infections.

Dr. Dave Singh, lead investigator on the trial, emphasized the significance of biologics in shaping COPD treatment paradigms, particularly for patients with elevated eosinophil counts.

The COURSE trial, a Phase 2a study, involved 337 patients globally and evaluated tezepelumab’s safety and efficacy over 52 weeks. Tezepelumab targets thymic stromal lymphopoietin (TSLP), a key cytokine involved in airway inflammation, with potential applications beyond COPD, including severe asthma and other respiratory conditions.

The collaboration between Amgen and AstraZeneca facilitates the joint development and commercialization of TEZSPIRE, with a focus on advancing treatments for respiratory diseases globally.