Regeneron Pharmaceuticals made a big splash last year with a drug prospect it believes just might hit the root cause of several allergic diseases. Today, it’s backing up that thesis with some new data showing that the drug might have a place treating one of the world’s most common skin disorders.
Tarrytown, NY-based Regeneron (NASDAQ: REGN) and partner Sanofi today are releasing positive results from a mid-stage trial testing their antibody drug hopeful, dupilumab, in patients with moderate to severe forms of atopic dermatitis—a skin condition commonly called eczema, which is characterized by intensely itchy red, scaly skin lesions (results from some earlier trials are also being published today in the New England Journal of Medicine). The data continue to fuel support for dupilumab, which has already showed promise as a treatment for allergic asthma. The two companies expect to kick off late-stage studies in atopic dermatitis in the U.S. and Europe later this year, according to Gianluca Pirozzi, the global project head for dupilumab at Sanofi.
Dupilumab is designed to work by blocking the signaling of the cytokines interleukin 4 and interleukin 13. Cytokines are signaling molecules that aid cell to cell communication in immune responses and stimulate the movement of cells towards sites of inflammation, infection, and trauma. The big idea here is that IL-4 and IL-13 may be key drivers of, potentially, a variety of allergic diseases—like eczema, certain forms of asthma, and nasal polyposis—opening up what could be big returns for the two companies if the drug can continue to produce good results. Last year, Regeneron, which discovered dupliumab with its in-house antibody technology, supported that idea with a mid-stage study in allergic asthma—in the 104-patient study, the drug was able to largely keep patients’ asthma from worsening, while improving their lung function.
Now, dupilumab appears to have potential in another market—atopic dermatitis. Pirozzi says that about 1 to 3 percent of the worldwide population has the disease, and roughly a third of those people have the moderate to severe forms of it. Patients are initially typically prescribed a variety of topical corticosteroid creams or phototherapy to control their eczema. While those treatments can be effective for many people, about 15 to 20 percent of those with more severe forms of the disease don’t respond, according to Pirozzi. Those patients often have to turn to broad immunosuppressive treatments, such as cyclosporine—which can only be used for a short time because of safety risks (and when those drugs are removed, the lesions return). This is where Regeneron and Sanofi are hoping to position dupilumab.
“The advantage here is for the first time you have a drug that can not only effectively solve the disease, but also can be given for a sustained effect over time,” Pirozzi says.
It’s still early, but the two companies are taking a step towards proving that today. They enrolled 380 patients with eczema that couldn’t be controlled by topical treatments and gave them either … Next Page »