Sanofi and Regeneron announce the success of its late-stage placebo-controlled trials for dupilumab, an injectable drug to treat uncontrolled moderate to severe atopic dermatitis (eczema), which affects more than 17 million Americans.
The Phase 3 study, which ran for 16 weeks, was participated by 1,379 adult patients whose eczema severity was comprehensively assessed before acceptance using tools such as Eczema Area and Severity Index (EASI). These patients also showed no improvement or response to topical treatments or are not suitable for such type of therapy.
The participants were then randomly chosen into three groups, all of whom were injected with 300 milligrams dupilumab, which works by disrupting the signaling pathways of IL-4 and IL-13 proteins, either once or twice a week except for the placebo group who received a single dose of the drug or the placebo.
The results suggest [PDF] that when compared to the placebo, those who received a dose either weekly or every two weeks showed significant improvement of symptoms.
In the first trial, 37 and 38 percent of patients who received the drugs weekly or every two weeks respectively experienced near or complete clearing of skin lesions compared to only 10 percent of the placebo.
In the second trial, 36 percent of those who received the drug either every week or every two weeks had clearing of skin while only 8.5 percent of the placebo experienced the same.
Overall, the non-placebo participants displayed a marked improvement in the common signs and symptoms of eczema with no side effects.
Although there are already existing topical treatments for eczema, they have been linked to immune suppression and risks of kidney damage. With this success, dupilumab becomes the first approved systemic drug for eczema without the need of suppressing the immune system.
The makers intend to submit the drug for regulation with the Federal and Drug Administration (FDA) in the third quarter of 2016. In the meantime, "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," said Regeneron president George D. Yancopoulos, MD. Ph.D.
On its part, Sanofi believes that the findings of the study will "bring new hope to atopic dermatitis patients, many of whom have suffered for years," expressed Sanofi president Elias Zerhouni.
Both companies hope to sell the drug in the market as soon as possible where it's expecting to fetch $30,000 a year.
Photo: Tony Bowden | Flickr