Regeneron and Sanofi’s dupilumab delivers in phase IIa for sinusitis

Regeneron Pharmaceuticals and Sanofi have announced more positive results for their novel drug dupilumab in the allergic inflammatory arena.

Their phase IIa proof-of-concept study of dupilumab, which works by blocking IL-4 and IL-13 signalling, met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps (CSwNP) who did not respond to intranasal corticosteroids. IL-4 and IL-13 are key cytokines that are required for the initiation and maintenance of the Th2 (Type 2 helper T-cell) immune response, which is believed to be a critical pathway in allergic inflammation.

In June, the companies began recruiting for phase III trials of dupilumab in eczema, following favourable results in phase IIb. These studies are expected to begin before the end of the year.

Analysts have suggested that the drug could hit blockbuster status if its promise is fulfilled by late-stage trial results.

Dr Gianluca Pirozzi, vice president, global project head at Sanofi, said, “Based on these results, we plan to move forward with further clinical development of dupilumab in patients with chronic sinusitis with nasal polyps, in addition to the ongoing development in atopic dermatitis and in asthma.”

In the study, dupilumab resulted in a statistically-significant improvement in the size of nasal polyps, as measured by endoscopic Nasal Polyp Score (NPS), the primary endpoint of the study. Statistically significant improvements in all secondary efficacy endpoints were also observed, including objective measures of sinusitis by CT scan, nasal air flow, and patient-reported symptoms. In a pre-specified exploratory analysis, dupilumab-treated patients who also had asthma demonstrated significant improvements in asthma control.

“There is growing recognition that patients suffering from one type of allergic disease often have additional allergic conditions. For example, many patients with chronic sinusitis with nasal polyps also have asthma or atopic dermatitis and vice versa,” explained Dr Neil Graham, vice president, programme management, at Regeneron. “The new data reported today, together with prior phase II data with dupilumab in asthma and atopic dermatitis, support the growing body of scientific evidence that these conditions may result from a core allergic inflammatory process driven by the IL-4/IL-13 pathway.”

The study enrolled 60 adult patients with moderate-to-severe CSwNP who received 300 mg of dupilumab or placebo administered once per week for 16 weeks, following an initial loading dose of 600 mg. They also received a standard-of-care nasal corticosteroid spray. Patients were eligible for the study if they continued to have severe CSwNP despite standard treatment for at least one month. Half of patients in the study had already had surgery for their condition. A total of 58 per cent also had asthma

Dupilumab was created using Regeneron’s VelocImmune technology and is being co-developed with Sanofi in atopic dermatitis, asthma and CSwNP.


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