Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) and Sanofi SA (ADR) (NYSE: SNY) announced their experimental drug for a debilitating skin condition called atopic dermatitis met all of its major treatment targets in two late-stage studies which is a key step in advancing a potential blockbuster medicine toward the market. Share of Regeneron Pharmaceuticals jumped up 13.25% to $ 408.81 during Friday trading.
The drug which named dupilumab substantially improved rash, itching and other symptoms of the condition, the companies said, which is a serious type of eczema that in its moderate to severe form affects about 1.6 million American adults and a significant number of children. By some estimates, as many as 3% of adults world-wide suffer from some form of the disease.
"These are the first Phase 3 studies of a systemic therapy to demonstrate a significant improvement in moderate-to-severe atopic dermatitis, a chronic, debilitating inflammatory disease that impacts over one million Americans," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "Dupilumab is the first in a new class of immunotherapies – in these 16 week trials, dupilumab blocked the aberrant activation of this pathway, resulting in significant efficacy without evidence of immune-suppressing side effects. We continue to evaluate the role of IL-4 and IL-13 signaling in related inflammatory conditions, including asthma and nasal polyposis, where we have ongoing dupilumab clinical development."
The data, disclosed in a news release, haven’t been peer-reviewed. The companies expect the results, which are in line with previously published smaller studies, will be presented at a medical conference soon. Under a program intended to expedite review of promising drugs for serious conditions, the U.S. Food and Drug Administration granted the drug “breakthrough” designation status in November 2014 based on the smaller studies.
The companies plan to file for FDA approval of the drug in the third quarter. A separate trial of the drug in children is under way.
In the new trials, involving a total of 1,379 adults treated for 16 weeks, the drug cleared or nearly cleared serious rashes in between 36% and 38% of patients treated with either a once-weekly or biweekly dose, the companies said. That compares to 8.5% to 10% of those on placebo.