If you want to understand why Regeneron R&D chief George Yancopolous gets a king's ransom in annual compensation, you need look no further than the Phase IIb data that has just been posted on dupilumab for severe eczema.
The drug, which is partnered with Sanofi ($SNY) in the pharma giant's premier biotech collaboration, was invented using antibody tech that Yancopolous co-invented. And in one high-dose group suffering from atopic dermatitis there was a mean reduction in disease severity of 74%. Skin clearing or near-clearing was achieved by 12% to 33% of all the patients in the drug arms.
Investigators credit the drug's one-two punch on interleukin-4 and interleukin-13, positioning this therapy for a late-stage study that promises to prove the drug can significantly move the dial on treatment for patients. If it's shown effective in Phase III, the drug can go on to compete against corticosteroids, which spur unwanted side effects by tampering too much with the body's immune system.
All of which helps explains why Regeneron's ($REGN) chief scientist has already tapped this one as a contender for blockbuster status, with another Phase IIb study reading out soon on allergic asthma.
"These clinical data, coupled with our Phase IIa results in asthma last year, support the growing scientific evidence that the IL-4/IL-13 pathway may be a fundamental driver in allergic diseases," said Yancopoulos in a statement. "Blocking IL-4/IL-13 signaling may provide an important new approach to atopic conditions, including asthma, atopic dermatitis and nasal polyposis, where we have ongoing clinical programs."
The big idea here is to treat eczema by zeroing in on IL-4/IL-13 without dismantling the immune system the way steroids do. And it's a notion that they have been advancing in the clinic while carving out clear leadership in the field, without having to compete with the myriad of rivals that often weigh in on skin conditions.
For Regeneron, which has been earning big bucks with Eylea, a successful late-stage effort here will help seal its reputation for cutting-edge drug development. For Sanofi, it's a chance to prove that its outspoken support of open collaboration can pay off handsomely with badly needed products. Dupilumab is now one of a half dozen or so programs that represent Sanofi's top late-stage assets for a company that has had limited success in recent years in the clinic.
Sanofi R&D chief Elias Zerhouni underscored that point in a recent sit-down with Bernstein's Tim Anderson, who keeps a close eye on the pharma giant's pipeline. Zerhouni "said of the 15 potential diseases to study, the greatest unmet need rests with atopic dermatitis where there is limited competition and the market is inadequately addressed because routine therapies like topical corticosteroids embed meaningful safety problems," reported Anderson.
Dupilumab is already in Phase III for atopic dermatitis, noted Anderson, which should wrap up in 2016.
- here's the release (PDF)