Sanofi and Regeneron made waves when they presented data from a phase 3 trial that showed that blockbuster Dupixent could become the first biologic to treat chronic obstructive pulmonary disease (COPD) and the first new therapy for the condition in more than a decade.
Two months later, Sanofi is again touting the advantages of Dupixent in COPD, along with the prospects of its other pipeline treatments for respiratory disorders.
These include SAR’765, the first novel biologic to target the IL-13 and thymic stromal lymphopoietin (TSLP) pathways. Early-stage data for SAR’765 suggest it has the potential to become the most effective biologic in asthma, the company said.
Sanofi presented results of the phase 1 study, along with an overall look at its respiratory disease pipeline, Monday morning at the American Thoracic Society International Conference in Washington, D.C.
Assembling a talented group of specialists, Sanofi has invested much in beefing up its respiratory diseases portfolio, according to its global medical head of immunology, Paul Rowe, M.D.
“We recognize that there are big players in the respiratory space and have been for number of years,” Rowe said in an interview. “We’re very proud of how far we’ve come in a relatively short period of time. We’re definitely playing with the big boys and girls.”
While SAR’765 is a long-range prospect, Dupixent is on the doorstep of proving itself in another major indication. In the phase 3 BOREAS trial of 939 patients ages 40 to 80 with COPD and evidence of type 2 inflammation, Dupixent aced its primary endpoint by delivering a 30% reduction in moderate or severe exacerbations compared to placebo over a 52-week period.
Now, Sanofi is pointing to the secondary benefits of lung function and quality of life improvements Dupixent provided to patients.
In forced expiratory volume (FEV)—a measure of the volume of air that can be exhaled—those on Dupixent reached 160mL versus 77mL for those on placebo over 12 weeks, with the benefit sustaining through 52 weeks. The differentiating effects of Dupixent in this category were seen two weeks into treatment.
Additionally, Dupixent patients reported an average increase of 9.7 points on a quality-of-life health measurement scale of 0 to 100. That compared with an improvement of 6.4 points for patients on placebo.
“To see such an improvement in lung function in patients that are this severe, it’s very encouraging,” Rowe said. “Not only are we impacting the exacerbations—the chronic drivers of the disease which cause hospitalization for these patients and obviously mortality—but they're also feeling better and reporting better movement of symptoms.”
Meanwhile, the companies are conducting a similar phase 3 trial of Dupixent in COPD. For the NOTUS study, they are recruiting current and former smokers aged 40 through 85 who are at risk for exacerbations. A readout of the trial is expected next year.
An approval to treat COPD—the world’s third-leading cause of death—would bring a massive market, estimated at 300,000 in the United States alone. Analysts with Evercore ISI have estimated a nod would open up a $3.5 billion sales opportunity, perhaps pushing Dupixent to more than $20 billion in sales by 2030.
The treatment raked in sales of $8.7 billion last year, a 44% increase from 2021. Dupixent was initially approved for eczema in 2017, followed by nods for asthma, rhinosinusitis, eosinophilic esophagitis and prurigo nodularis.