NAPSR news: Sanofi/Regeneron's DUPILUMAB Indicates Positive Results for Severe Eczema Treatment

WASHINGTON - July 10, 2014 - PRLog -- Sanofi and Regeneron announced successful results from a Phase2b study of the investigational therapy dupilumab to treat adult patients with moderate to severe atopic dermatitis (AD) which is also a chronic form of Eczema. Dupilumab is a fully-human monoclonal antibody and was created using Regeneron's revolutionary VelocImmune® technology and is being co-developed with Sanofi in atopic dermatitis, asthma and nasal polyposis.

Clinical data was collected based on a Phase 2b double-blind, placebo-controlled, 16-week, dose-ranging study  of 380 patients suffering from moderate to severe AD who in randomized order, received one of five doses of dupilumab (300 mg weekly, 300 mg every other week, 300 mg monthly, 200 mg every other week, 100 mg monthly) or placebo.

According to a press release issued by both companies, the results of the study compared to placebo after 16 weeks of treatment are seen below:

·        •12 percent to 33 percent of dupilumab-treated patients achieved clearing or near-clearing of skin lesions, as measured by an investigator’s global assessment (IGA) score of 0 or 1, compared to 2 percent with placebo. (p=0.02 to p<0.0001)

·      •  Dupilumab-treated patients experienced a 16.5 percent to 47 percent mean reduction in itching, as measured by the pruritus numerical-rating scale (NRS) score, compared to an increase of 5 percent in the placebo group.  (p=0.0005 to p<0.0001)

"Atopic dermatitis is known to have a profoundly negative effect on quality of life and people with more severe forms of this disease have limited therapeutic choices,” said Elias Zerhouni, MD, President, Global R&D, Sanofi. “These latest results are consistent with what was observed in the earlier clinical studies and add to the body of evidence that investigational dupilumab may have a role to play for patients with moderate-to-severe atopic dermatitis. We are now able to select the optimal doses for the phase 3 studies, which we anticipate to begin later this year.”

The drug still needs to be subject to regulatory approval however, dupilumab is one of the key drugs being jointly developed through collaboration between both companies. Sanofi, which had global sales of 33 billion euros last year, has paid more than $2 billion to fund drug discovery and development at Regeneron, a N.Y.-based biotechnology known for its scientific dexterity.

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