Regeneron and Sanofi‘s Blockbuster Drug Hits the Mark in Two Phase III trials

Exterior view of Regeneron building

Shares of Regeneron jumped more than 5 percent Monday after the company announced that its blockbuster drug Dupixent (dupilumab) hit the mark in two Phase III trials studying the drug as a treatment for adults with inadequately-controlled chronic rhinosinusitis with nasal polyps.

Regeneron and its developmental partner Sanofi said Dupixent met all primary and secondary endpoints in the two late-stage trials. The two companies said they intend to take the data from the two trials and use it as a platform to seek regulatory approval for this indication. Dupixent, which was approved by the U.S. Food and Drug Administration (FDA) last year as a treatment for atopic dermatitis, inhibits signaling of IL-4 and IL-13, two key cytokines involved with the inflammation associated with dermatitis, a Type 2 allergic inflammatory disease. In May of this year, the companies signaled plans to seek regulatory approval for Dupixent as a potential monotherapy treatment for moderate-to-severe atopic dermatitis in adolescents. In March, Regeneron and Sanofi filed a supplemental Biologics License Application for Dupixent as an add-on maintenance for people with moderate-to-severe asthma.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a chronic disease in which Type 2 or allergic inflammation causes polyps that obstruct the sinus and nasal passages, The obstruction and inflammation can lead to severe congestion, nasal discharge, facial pain or pressure and reduced sense of smell and taste. In the two late-stage CRSwNP trials, patients treated with Dupixent and a standard-of-care corticosteroid nasal spray experienced a 51 percent and 57 percent improvement in their nasal congestion/obstruction severity compared to a 15 percent and 19 percent improvement with nasal spray alone. Additionally, trial data showed that Dupixent-treated patients had a 27 percent and 33 percent reduction in their nasal polyps score compared to a 4 percent and 7 percent increase for the nasal spray, Regeneron and Sanofi said.

Dupixent also met all secondary endpoints in both trials, including demonstrating a significant reduction in the need for systemic corticosteroids or surgery, and improvements in smell and chronic rhinosinusitis symptoms. The two companies also noted that in a pre-specified group of patients with comorbid asthma, Dupixent significantly improved lung function and asthma control.

Among the patients involved in the two Phase III Dupixent trials, Regeneron and Sanofi said more than half had previously undergone surgery for their nasal polyps. Additionally, about three-quarters of the trial participants had used systemic corticosteroids within the past two years. Detailed results from these trials will be submitted for presentation at future medical meetings, the companies said.

George D. Yancopoulos, president and chief scientific officer of Regeneron, said Dupixent has demonstrated “significant late-stage efficacy in three Type 2 or allergic inflammatory diseases,” meaning atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyps. Yancopoulos said that indicated that IL-4 and IL-13 are required drivers of Type 2 or allergic inflammation in general.

“With these data, Dupixent has now been shown to address this inflammation across the complete airway, which manifests in the upper respiratory tract as polyps and congestion, and in the lower airway as asthma,” Yancopoulos said in a statement. “We look forward to U.S. regulatory action on our moderate-to-severe asthma application later this month, and we are continuing our development program in additional Type 2 or allergic inflammatory diseases with high unmet need including pediatric asthma, pediatric and adolescent atopic dermatitis, eosinophilic esophagitis, and food and environmental allergies.”

The rates of adverse events were generally similar across Dupixent and placebo, and no new or unexpected side effects related to Dupixent were observed, the companies said.

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