September 30, 2014
By Mark Terry, BioSpace.com Breaking News Staff
In potential good news for sinus, allergy and asthma sufferers, Regeneron Pharmaceuticals and Paris-based Sanofi today announced successful completion of a Phase 2a proof-of-concept study of dupilumab.
Dupilumab blocks IL-4 and IL-13 signaling and shows effectiveness in the treatment of moderate-to-severe chronic sinusitis with nasal polyps (CSwNP).
The study was a randomized, double-blind, placebo-controlled study of 60 adults with CSwNP. The patients received 300 mg of the compound or a placebo administered once a week for 16 weeks after receiving a 600 mg loading dose. In addition, all patients received standard-of-care nasal corticosteroid spray. About 58 percent of the patients also had asthma, which is often co-morbid with CSwNP.
The trial met all primary and secondary endpoints. The primary endpoint was statistically-significant improvement in the size of nasal polyps measured by endoscopic Nasal Polyp Score (NPS). Secondary efficacy endpoints included objective measurements 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. Although asthma symptoms were not the primary focus of the study, the researchers also found that patients with asthma in the study showed significant improvements.
“These data suggest the potential of dupilumab for use in the treatment of another allergic inflammatory condition,” said Sanofi vice president, Global Project Head Gianluca Pirozzi, in a statement. “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.”
The Tarrytown, N.Y.-based company is on something of a roll, having recently announced that Bayer HealthCare’s Japanese subsidiary, Bayer Yakuhin, Ltd., had received approval from the Japanese Ministry of Health, Labour and Welfare for EYLEA (aflibercept) Injection, a treatment for patients with neovascular age-related macular degeneration.
The company has also submitted marketing authorization to Japan for the compound’s treatment of diabetic macular edema and macular edema secondary to branch retinal vein occlusion. The drug is already approved in the U.S., European Union and other countries. EYLEA is part of a global development agreement between Bayer Healthcare and Regeneron.
Earlier conversations with Regeneron executives have indicated the company is very optimistic about this sinusitis drug. “We have a lot of debate within the company as to which of our many programs is the most exciting,” said Regeneron research chief George Yancopoulos in a statement, “and a lot of people are voting on dupilumab.”
