Sanofi and Regeneron’s Dupixent appears set up for a key FDA approval this summer for chronic obstructive pulmonary disorder (COPD). But a second biologic treatment could be on its heels in the indication.
Amgen and AstraZeneca have reported data that did not meet the primary endpoint of a phase 2a trial but did show the effectiveness of their asthma drug Tezspire (tezepelumab) in certain patients with the breathing disease.
In the COURSE study—which enrolled a broad population of COPD patients—Tezspire produced a 17% reduction versus placebo in moderate or severe COPD exacerbations at week 52. While that result did not reach statistical significance, there were promising numbers for certain patient subgroups in the trial, the partners said.
In those with blood eosinophil counts (BEC) of 150 cells or greater/µL (per microliter), Tezspire provided a 37% reduction in moderate or severe exacerbations. In those with a BEC of 300 cells or higher per microliter, there was a 46% reduction in moderate or severe exacerbations.
Both the figures were nominally significant, which is noteworthy considering that 65% of COPD patients who are eligible for biologics have baseline BECs of 150 or more. The companies revealed the data at the American Thoracic Society (ATC) international conference Sunday in San Diego.
“These proof-of-concept results from the COURSE trial are encouraging as they signal the potential efficacy of tezepelumab in a broad range of people with COPD irrespective of emphysema, chronic bronchitis and smoking status,” Sharon Barr, AZ’s biopharmaceuticals R&D chief, said in a release.
Barr and Amgen’s chief scientific officer and R&D chief Jay Bradner, M.D., added that the companies are planning to run a phase 3 trial of tezepelumab in COPD.
On the surface, AZ and Amgen’s study indicates the potential superiority of Tezspire over Dupixent in the indication. Data from the phase 3 BOREAS and NOTUS studies—which enrolled patients with BEC counts of at least 300 cells or higher and with type 2 inflammation—showed that Dupixent provided reductions of 30% and 34%, respectively, in moderate or severe exacerbations.
Sanofi and Regeneron are hoping for FDA approval of Dupixent by the agency's June 27 target decision date. Earlier this month, however, Regeneron said that the nod could be delayed as the FDA has requested sub-population breakdowns from the two trials.
The approval has been closely watched as analysts at Evercore ISI believe that a COPD indication would add $3.5 billion to Dupixent’s peak sales potential, pushing it to the $20 billion range by the end of this decade.
Verona Pharma is also set up for a potential FDA approval in COPD next month for its inhaled maintenance treatment ensifentrine. GlobalData has projected sales for the anti-inflammatory treatment to reach $1.05 billion in 2029.
In AZ and Amgen’s COPD trial, which started in July of 2019, Tezspire also provided improvements in lung function and quality of life scores. The most frequently reported adverse events were a worsening of COPD in 12% of patients and a 14.5% higher incidence of COVID-19.
Tezspire was approved for severe asthma in December of 2021. Worldwide sales reached $653 million in 2023, up from $174 million in its first year on the market.
Approximately 300,000 in the U.S. have COPD with type 2 inflammation. COPD is the third-leading cause of death according to the World Health Organization, which attributed 3.2 million deaths to the disorder in 2019. In the U.S. and Europe, 70% of COPD patients are current or former smokers. There have been no significant treatment advances in the indication in more than a decade.