PARIS (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNYNF, SNY) said a Phase 2a proof-of-concept study of dupilumab met 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 is an investigational therapy that blocks IL-4 and IL-13 signaling. A fully-human monoclonal antibody, it is directed against the IL-4 receptor alpha subunit, which blocks signaling from both IL-4 and IL-13.
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.
'These data suggest the potential of dupilumab for use in the treatment of another allergic inflammatory condition,' said Gianluca Pirozzi, M.D., PhD, Vice President, Global Project Head at Sanofi.
In the study, dupilumab resulted in a statistically-significant improvement in the size of nasal polyps, 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 like sense of smell, congestion, postnasal drip, runny nose and sleep disturbance.
In a pre-specified exploratory analysis, dupilumab-treated patients who also had asthma demonstrated significant improvements in asthma control.
The safety profile was consistent with previous studies. The most common adverse events with dupilumab were injection site reactions, nasopharyngitis, oropharyngeal pain, epistaxis, headache and dizziness.
The randomized, double-blind, placebo-controlled study enrolled 60 adult patients with moderate-to-severe CSwNP.
Patients in the study received 300 milligrams of dupilumab or placebo administered once per week subcutaneously for 16 weeks, following an initial loading dose of 600 mg.
All patients in the study 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. Fifty percent of patients in the study had received prior surgery for their condition. Asthma was also present in 58 percent of CSwNP patients in the study.
Detailed results of the study will be presented at an upcoming medical conference.
Neil Graham, M.D., Vice President, Program Management at Regeneron, said the new data, together with prior Phase 2 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.
Based on these results, the firm plans 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.
REGN closed down 0.9 percent on Monday at $354.96, while Sanofi settled in Paris at 87.61 euros.
Copyright RTT News/dpa-AFX