PARIS (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) and French drug maker Sanofi (SNYNF.PK, SNY) announced that a Phase 2a proof-of-concept trial of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, achieved all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps or CSwNP, who did not respond to intranasal corticosteroids.
Dupilumab, a fully-human monoclonal antibody, is directed against the IL-4 receptor alpha subunit, which blocks signaling from both IL-4 and IL-13.
Gianluca Pirozzi, M.D., Vice President, Global Project Head at Sanofi stated: 'These data suggest the potential of dupilumab for use in the treatment of another allergic inflammatory condition.' He added, '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.'
During the study, dupilumab led to statistically-significant improvement in the size of nasal polyps, as measured by endoscopic Nasal Polyp Score, the primary endpoint of the trial. 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.
The randomized, double-blind, placebo-controlled study enrolled 60 adult patients with moderate-to-severe CSwNP. According to the company, Asthma was also present in 58 percent of CSwNP patients in the study.
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