Sanofi chases fourth Dupixent nod after late-stage eosinophilic esophagitis trial win

 Sanofi’s plan to build Big Pharma’s “strongest franchise in immunology” hinges on lead product Dupixent, the company’s chief financial officer, Jean-Baptiste Chasseloup de Chatillon, recently said. Now, the French drugmaker is touting the med’s potential to snag a fourth indication for a chronic inflammatory disease that makes eating and drinking a struggle.

Sanofi and Regeneron's Dupixent, also known as dupilumab, notched a win in a phase 3 study of patients with eosinophilic esophagitis (EoE), Sanofi said in a late-breaking abstract debuted Saturday at the 2022 annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI). 

At the study’s 24-week mark, a 300 mg dose of weekly Dupixent “significantly” trumped placebo when it came to improving the signs and symptoms of EoE, Sanofi said in a release. The study looked at the monoclonal antibody in 159 EoE patients ages 12 and older. 

Eighty patients in the study received Dupixent, while 79 were assigned placebo. Among those on Sanofi’s monoclonal antibody, 64% saw a reduction in disease symptoms from baseline versus 41% in the control arm. Specifically, patients on Dupixent saw a 23.78 point improvement on the Dysphagia Symptom Questionnaire—a patient reported measure of difficulty swallowing—versus a 13.86 improvement in the placebo cohort. 

Meanwhile, nearly 10 times as many patients on Dupixent hit histological disease remission at 59%, versus just 6% in the placebo group. Sanofi said it will roll out detailed results on a two-week dosing regimen at an upcoming medical meeting. 

With a winning readout in hand, Sanofi has submitted its Dupixent EoE data to the U.S. FDA. The company says it plans to file for approval in other countries later this year. 

“Eosinophilic esophagitis can greatly impact a person’s ability to eat normally, and physicians have to rely on invasive medical procedures to monitor and, in more serious cases, stretch the esophagus,” Evan Dellon, M.D., M.P.H., a professor of gastroenterology and hepatology and co-principal investigator of the Dupixent EoE trial, said in a statement. “Currently, there are no FDA-approved treatment options that address the underlying drivers of this disease.”

Sanofi estimates there are about 160,000 EoE patients in the U.S. who are currently being treated, of whom some 48,000 have failed multiple treatments.

EoE is a chronic, progressive type 2 inflammatory disease that damages the esophagus and keeps it from working correctly. For patients with the disease, “swallowing the smallest amount of food or taking a sip of water can be a painful and worrisome choking experience,” Sanofi noted. The disease can cause the esophagus to narrow, too, which may need to be treated by physically expanding the organ, which is often painful. 

Dupixent in 2020 scored an FDA breakthrough therapy tag in EoE. It won orphan drug designation for potential treatment of the disease back in 2017. 

Last year, Dupixent garnered full-year sales of 5.25 billion euros (around $6 billion), Sanofi said in its annual report published earlier this month.

Thanks to its strong Dupixent momentum in 2021, Sanofi has set the goal to "build the strongest franchise in immunology among big pharma," CFO Chasseloup de Chatillon said in January at the 2022 J.P. Morgan Healthcare Conference. The company aims to generate €10 billion or more from the drug at peak. 

https://www.fiercepharma.com/pharma/sanofi-chases-fourth-dupixent-nod-back-eosinophilic-esophagitis-win