Sunday, Amgen Inc (NASDAQ:AMGN) and AstraZeneca Plc (NASDAQ:AZN) announced the results of the Phase 2a COURSE trial of Tezspire (tezepelumab-ekko) for severe chronic obstructive pulmonary disease (COPD) with a broad range of baseline blood eosinophil counts (BEC) 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 (p[1-sided]=0.1042).
The proof-of-concept study showed that, in patients with BEC ≥150 cells/μL, tezepelumab led to a nominally significant reduction of 37% in the rate of moderate or severe exacerbations compared to placebo.
Among patients with BEC ≥300 cells/μL, tezepelumab led to a numerical reduction of 46% in the rate of moderate or severe exacerbations.
A subgroup analysis of the COURSE trial also showed that treatment with tezepelumab resulted in numerical improvements in lung function as measured by forced expiratory volume (FEV1) (improvement of 63 mL and 146 mL in BEC ≥150 and ≥300 cells/μL respectively, compared to placebo) and in quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ) score (reduction of 4.2 points and 9.5 points in BEC ≥150 and ≥300 cells/μL respectively).
The safety and tolerability profile for tezepelumab was consistent with its approved severe asthma indication.
Price Action: AMGN shares are up 0.40% at $313.74, and AZN shares are up 0.18% at $77.04 at last check Monday.
Photo by Minerva Studio via Shutterstock