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Trial suggests Sanofi's asthma drug works in sinusitis

Dupilumab able to reduce polyp size in sinusitis patients
Sanofi reception

Sanofi's asthma drug dupilumab is also an effective treatment for patients with chronic sinusitis who develop nasal polyps, according to mid-stage trials.

The phase IIa proof-of-concept study showed that dupilumab - originally developed by Regeneron - was able to reduce polyp size in patients with moderate-to-severe chronic sinusitis who failed to respond to intranasal corticosteroid therapy.

While some people who have chronic sinusitis with nasal polyps (CSwNP) can manage symptoms such as nasal congestion, disrupted smell and sleep problems with steroids, for many others these drugs are ineffective. For them, the only recourse is sinus surgery and around 200,000 CSwNP patients opt for this procedure every year.

The results indicate that treatment with dupilumab - which targets interleukin-4 (IL-4) and interleukin-13 (IL-13) - resulted in a statistically significant improvement in the size of nasal polypsmas measured by endoscopic nasal polyp score (NPS), according to Sanofi. The drug was also able to alleviate patient-reported symptoms.

Dupilumab is being developed in the first instance as a treatment for asthma, which has some overlap with CSwNP as around a third of chronic sinusitis patients also have the respiratory disease, as well as atopic dermatitis.

"There is growing recognition that patients suffering from one type of allergic disease often have additional allergic conditions," commented Neil Graham, vice president, programme management at Regeneron, who added the partner companies would now press on with additional studies of the drug in CSwNP.

"Many patients with CSwNP also have asthma or atopic dermatitis and vice versa," he added, noting that in the phase IIa trial around 60% of patients had both asthma and CSwNP and reported significant improvements in symptoms of both conditions.

Dupilumab is one of a number of interleukin-targeting drugs being developed for asthma and related inflammatory conditions, including anti-IL-5 candidates from GlaxoSmithKline (mepolizumab), Teva (reslizumab) and AstraZeneca (benralizumab) and an anti-IL-13 antibodies from AZ (tralokinumab).

They are generally being positioned as steroid-sparing agents, which is desirable as the latter drugs can have side effects such as weight gain, diabetes, high blood pressure and glaucoma, and are widely expected to usher in a new therapeutic category with sales potential of several billion dollars a year. However, questions are already being raised about the affordability of biologic therapy for asthma.

For Sanofi, dupilumab is a key pipeline candidate - along with cholesterol antibody alirocumab and anti-IL-6 antibody sarilumab for rheumatoid arthritis - after a fairly weak period for the company in terms of new product launches. All three of the antibodies have originated from its alliance with Regeneron.

Article by
Phil Taylor

1st October 2014

From: Research

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