Amgen and AstraZeneca Find Tezspire Promising for COPD Despite Trial Miss

AstraZeneca and Amgen's biologic Tezspire, initially approved for severe asthma in 2021, is showing promise for treating chronic obstructive pulmonary disorder (COPD). Findings from a recent phase 2a trial suggest that Tezspire could eventually gain an additional indication for COPD.

Sanofi and Regeneron’s Dupixent are also in the race for FDA approval for COPD treatment, expected this summer. However, Tezspire could emerge as a strong competitor. Although the phase 2a trial did not meet its primary endpoint, it demonstrated Tezspire's efficacy in certain COPD patients.

The COURSE study, which included a diverse group of COPD patients, revealed that Tezspire achieved a 17% reduction in moderate or severe COPD exacerbations compared to placebo at the 52-week mark. While this result was not statistically significant, notable effectiveness was observed in specific patient subgroups. For patients with blood eosinophil counts (BEC) of 150 cells or more per microliter, Tezspire resulted in a 37% reduction in moderate or severe exacerbations. For those with BECs of 300 cells or higher, the reduction was 46%. These figures are particularly significant given that 65% of COPD patients eligible for biologics have baseline BECs of 150 or higher. The data was presented at the American Thoracic Society (ATC) international conference in San Diego.

Sharon Barr, AstraZeneca’s biopharmaceuticals R&D head, noted that the trial results are encouraging, indicating potential efficacy across a broad spectrum of COPD patients, regardless of emphysema, chronic bronchitis, or smoking history. Both AstraZeneca and Amgen plan to conduct a phase 3 trial for Tezspire in COPD.

Comparatively, Tezspire may outperform Dupixent in COPD treatment. Data from phase 3 BOREAS and NOTUS studies showed that Dupixent led to reductions of 30% and 34%, respectively, in moderate or severe exacerbations in patients with BECs of at least 300 cells and type 2 inflammation. Sanofi and Regeneron are targeting an FDA approval date of June 27, although there could be delays due to the FDA's request for detailed sub-population data.

Market analysts believe that a COPD indication for Dupixent could significantly boost its sales, potentially adding $3.5 billion to its peak sales, pushing its total to around $20 billion by the end of the decade.

Meanwhile, Verona Pharma is also seeking FDA approval for its inhaled maintenance treatment ensifentrine for COPD, with anticipated sales reaching $1.05 billion by 2029.

In the COPD trial started in July 2019, Tezspire also showed improvements in lung function and quality of life scores. The most commonly reported adverse events were a worsening of COPD in 12% of patients and a 14.5% higher incidence of COVID-19.

Since its approval for severe asthma in December 2021, Tezspire’s sales have grown significantly, reaching $653 million in 2023, up from $174 million in its debut year. Approximately 300,000 people in the U.S. suffer from COPD with type 2 inflammation, a condition which the World Health Organization identifies as the third leading cause of death worldwide, attributing 3.2 million deaths to it in 2019. In the U.S. and Europe, a significant majority of COPD patients are current or former smokers. There have been no considerable advancements in COPD treatment for more than a decade.