Amgen announces results of Phase 2a COURSE trial evaluating Tezspire

Amgen (AMGN) and AstraZeneca (AZN) announced the results of the Phase 2a COURSE trial evaluating Tezspire in people with moderate to very severe chronic obstructive pulmonary disease with a broad range of baseline blood eosinophil counts irrespective of emphysema, chronic bronchitis or smoking status. The primary results showed that treatment with Tezspire led to a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52, which was not statistically significant. The results will be featured in presentations at the American Thoracic Society International Conference, May 17-22, in San Diego. Importantly, this proof-of-concept study showed that, in patients with BEC greater than or equal to150 cells/microL, tezepelumab led to a nominally significant reduction of 37% in the rate of moderate or severe exacerbations compared to placebo. Studies suggest that approximately 65% of bio-eligible patients with COPD have a BEC greater than or equal to 150 cells/muL. Among patients with BEC greater than or equal to300 cells/microL, tezepelumab led to a numerical reduction of 46% in the rate of moderate or severe exacerbations. Trends towards improved outcomes were also seen with tezepelumab use for pre-bronchodilator FEV1 and SGRQ total score. A subgroup analysis of the COURSE trial also showed treatment with tezepelumab resulted in numerical improvements in lung function as measured by forced expiratory volume and in quality of life as measured by the St. George’s Respiratory Questionnaire score. The safety and tolerability profile for tezepelumab was consistent with its approved severe asthma indication; the most frequently reported adverse events for tezepelumab were worsening of COPD and incidents of COVID-19 infections.