Sanofi and Regeneron's Dupixent scores trial win in tough-to-treat COPD

As a treatment for asthma, Dupixent helps patients breathe. Appropriately enough, Sanofi and Regeneron are breathing easy after Dupixent posted impressive data in a high-risk trial assessing its effectiveness against chronic obstructive pulmonary disease (COPD).

The phase 3 study met its primary and secondary endpoints, setting Dupixent up to become the first biologic treatment for the disorder, which has seen few advancements over the last decade and is the world’s third leading cause of death.

The study compared Dupixent to placebo in 939 COPD patients with type 2 inflammation who were active or former smokers on maximal standard-of-care inhaled therapy. Dupixent showed a clinically significant 30% reduction in moderate or severe exacerbations over 52 weeks.

With the result, Dupixent becomes the first antibody to limit COPD events while also demonstrating improvements in lung function, quality of life and COPD respiratory symptoms.

Dupixent appears set to succeed where other biologics—such as GSK’s Nucala and AstraZeneca’s Fasenra—have failed. The difference? While Nucala and Fasenra target IL-5 proteins, Dupixent targets the IL-4 and IL-13 pathways.

“Unfortunately, many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limited treatment options,” Dietmar Berger, M.D., Ph.D., Sanofi’s chief medical officer, said in a release. “We took a bold approach with our direct to phase 3 program, shaving years off standard clinical development timelines.”

COPD causes progressive lung function decline. But the companies hope that Dupixent can become the first treatment to reverse the progression, according to Paul Rowe, M.D., Sanofi’s head of global medical, immunology.

“Dupixent has an effect on blocking the action of those cytokines,” Rowe said in an interview last week. “By blocking those cytokines we’re able to potentially also impact the inflammation and hence, have a chance at impacting those irreversible causes.”

Originally approved in 2017 for eczema, soon to be followed by a nod to treat asthma, Dupixent has added FDA endorsements for three more inflammatory conditions, earning the distinction as a “pipeline in a drug.”

Dupixent rang up sales of $8.7 billion last year, which was a 40% increase from 2021, and is projected by Evaluate Pharma’s consensus to reach $18 billion in sales in 2028.