Phase III Results Prime Dupixent as First Potential Biologic Approval for COPD
Pictured: A doctor holds a chest x-ray/courtesy of iStock
Sunday, Sanofi and Regeneron released positive Phase III results for their blockbuster drug Dupixent in chronic obstructive pulmonary disease in current and previous smokers.
The trial enrolled 939 adults with moderate-to-severe chronic obstructive pulmonary disease (COPD). Patients treated with Dupixent, an anti-inflammatory biologic, experienced a 30% reduction in COPD exacerbations over 52 weeks compared to those on placebo, the primary endpoint. Improved lung function was seen at 12 weeks and sustained for the full length of the trial.
The results are a significant improvement to the maximal inhaled therapy that the Dupixent and placebo arms were receiving. Additional health-related quality of life was reported by patients, along with a reduction in respiratory symptom severity.
First approved for atopic dermatitis in 2017, Dupixent has since been greenlit for four other inflammatory diseases, including asthma. Dupixent is listed in over a dozen active Phase III trials for inflammatory conditions.
Shown to decrease type 2 inflammation, the drug’s developers “took a bold approach” by jumping straight into a Phase III trial for COPD, “shaving years off standard clinical development timelines,” Dietmar Berger, head of global R&D at Sanofi, said in a statement when a summary of results was shared in March.
Dupixent is a monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways. If approved, it would be the first biologic on the market for COPD.
In previous years, biologics from GlaxoSmithKline and AstraZeneca failed to prove efficacy for COPD, even after scoring approval in asthma. Both therapeutics inhibit IL-5.
Currently, 300,000 patients in the U.S. are living with uncontrolled COPD, according to Sanofi and Regeneron. Analysts believe Dupixent could snag 30% of that market, generating an estimated $2.5 billion in sales in the U.S. alone.
Sales of the drug in 2022 were close to $9 billion, with Sanofi targeting $10.8 billion in 2023. The forecasted increase in sales for the French drugmaker comes as Aubagio loses patent protection and faces generic competition. The multiple sclerosis pill pulled in $2.2 billion in sales last year.
Sanofi had already launched a second COPD trial, due to be completed in 2024, to prove Dupixent’s efficacy, but the company is hopeful for approval sooner.
“We will take these results to regulators and have a discussion about what can be done ahead of the read-out of the second trial,” Naimish Patel, head of global development for immunology and inflammation at Sanofi, said on Sunday at the American Thoracic Society International Conference.
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.