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news.US-based Regeneron Pharmaceuticals and French pharmaceutical firm Sanofi have reported positive results from a Phase IIa proof-of-concept trial of dupilumab in patients with chronic sinusitis with nasal polyps (CSwNP).
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Dupilumab is an investigational therapy that blocks IL-4 and IL-13 signaling.
The results showed that dupilumab met all primary and secondary endpoints in these patients who did not respond to intranasal corticosteroids.
Dupilumab also resulted in improving the size of nasal polyps, as measured by endoscopic Nasal Polyp Score (NPS), the primary endpoint of the trial.
The trial also showed statistically significant improvements in all secondary efficacy endpoints, including objective measures of sinusitis by CT scan, nasal air flow, and patient-reported symptoms such as sense of smell, congestion, postnasal drip, runny nose and sleep disturbance.
The most common adverse events observed with dupilumab were injection site reactions, nasopharyngitis, oropharyngeal pain, epistaxis, headache and dizziness.
Sanofi vice-president and global project head Gianluca Pirozzi said the data suggest the potential of dupilumab for use in the treatment of another allergic inflammatory condition.
"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," Pirozzi said.
A total of 60 adult patients with moderate-to-severe CSwNP were enrolled in the randomized, double-blind, placebo-controlled Phase IIa trial and they were given 300mg of dupilumab or placebo once per week (QW) subcutaneously for 16 weeks, following an initial loading dose of 600mg.
Regeneron vice-president of Program Management Neil Graham said 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," Graham said.
"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."