Sanofi-Regeneron drug has positive trial results in chronic sinusitis

[September 30, 2014]  By Natalie Huet

PARIS (Reuters) - An experimental drug from Sanofi and Regeneron significantly reduced congestion in in a mid-stage trial on patients with chronic sinusitis with nasal polyps, a condition poorly controlled by existing drugs, the companies said on Tuesday.

In a Phase IIa trial of dupilumab in patients who did not respond to intranasal corticosteroids, the injectable drug brought a statistically significant reduction in the size of nasal polyps and improved other symptoms such as congestion and sleep disruption, Sanofi said.

Dupilumab is also being tested by the drugmakers against two other allergic conditions - atopic dermatitis and asthma. The drug was named "clinical advance of the year" in 2013 by industry publication Scrip Intelligence, and some analysts say it could capture annual sales of up to $2 billion if approved.

Chronic sinusitis with nasal polyps causes inflammation of the mucosa and polyps in the nasal cavity and sinuses, resulting in congestion, a reduced sense of smell and facial pain.

Patients gain limited relief from intranasal corticosteroids, the only therapy currently available. Dupilumab works through a new approach, by blocking two proteins linked to inflammation, interleukin-4 (IL-4) and interleukin-13 (IL-13)

Sanofi said the findings of the trial on 60 adults with moderate-to-severe disease, combined with previous encouraging Phase II data for dupilumab in asthma and atopic dermatitis, supported evidence that these conditions may result from a core allergic inflammatory process driven by the IL-4/IL-13 pathway.

About 30 percent of patients with chronic sinusitis with nasal polyps also have asthma, and in an exploratory analysis, dupilumab-treated patients with both conditions also experienced significant improvement in asthma control, Sanofi noted.

The drug's main side effects were injection site reactions, common cold, sore throat, nosebleed, headache and dizziness.

Sanofi said it would present detailed results of the study at a medical conference and pursue further clinical trials.

(Editing by David Goodman)

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