Sanofi and Regeneron Pharmaceuticals Inc. said they plan to test their experimental eczema treatment in large late-stage studies after a smaller trial reduced symptoms of the scaly, itching disease.
In a trial among 380 adults with moderate to severe atopic dermatitis for whom steroid creams didn’t work, Sanofi’s dupilumab reduced symptoms by as much as 74 percent over four months, compared with 18 percent for those who received a placebo, the Paris-based drugmaker said in a statement today.
Sanofi said it plans to start the third and final stage of trials usually needed for regulatory approval later this year. The company is also testing the drug, which blocks proteins called IL-4 and IL-13, in patients with asthma and nasal growths.
“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,” Elias Zerhouni, Sanofi’s head of research and development, said in the statement.
As many as 20 percent of children and 3 percent of adults globally have atopic dermatitis, also known as eczema, and most people get it before their 5th birthday, according to the American Academy of Dermatology. The disease can cause oozing or dry, scaly, itchy rashes and areas of thickened skin. The most common treatments are corticosteroids, ultraviolet light or immunosuppressant drugs such as cyclosporine that can cause high blood pressure and kidney problems.
In the trial, dupilumab cleared or almost cleared skin lesions in as many as 33 percent of those who got it, compared with 2 percent of patients in the placebo group, and reduced itching by as much as 47 percent, while those who received a placebo had more itching.
Separately, results from four early-stage trials of dupilumab were published today in the New England Journal of Medicine, showing that dupilumab had a “marked and rapid” effect on disease symptoms.
Sanofi gained dupilumab as part of an alliance with Tarrytown, New York-based Regeneron, in which it owns a 21 percent stake.