Exclusive: Regeneron, Sanofi outline promising PhIIb data for top blockbuster pick dupilumab

Just days ago, Regeneron ($REGN) chief scientist George Yancopoulos tapped dupilumab as the next antibody in the pipeline likely destined for blockbuster status, following its late-stage PCSK9 leader Praluent (alirocumab). Today, the company and its close partner Sanofi ($SNY) helped explain why, posting another set of promising results for this drug--which targets the interleukin-4 and interleukin-13 inflammatory proteins--from a Phase IIb study that backs up those high expectations.

Regeneron CSO George Yancopoulos

Investigators say the dose-ranging study for atopic dermatitis, or eczema, produced some clear supporting data for the Phase III program, which has already begun. Among the 380 patients with moderate to severe cases of atopic dermatitis recruited for this midstage study, anywhere from 20% to 54% of the patients in various cohorts reported significantly reduced itching at 16 weeks compared to 8.2% in the placebo arm. There was also a distinct improvement in depression and anxiety--a 66.7% to 75% decrease in the drug arms compared to a 22.2% drop in the placebo group.

The data follows another promising Phase IIb snapshot for asthma last fall, with a third program for chronic sinusitis underway.

Dr. Weily Soong

Atopic dermatitis "is a horrible form of torture," says Dr. Weily Soong of the Alabama Allergy & Asthma Center in Birmingham, who presented the data today at the 2015 annual meeting of the American Academy of Allergy, Asthma & Immunology in Houston. "It's not a deadly disease, but in terms of quality of life, the misery index, it's way high."

Patients often suffer from the worst eczema at night, frequently leaving them sleepless, while the steady itching and scratching also leaves some very visible effects on the skin.   

The disease is typically treated with corticosteroids, but the affliction tends to rebound quickly and the steroids' substantial side effect profile only adds to the misery of this patient group.

A spokesperson for Regeneron says the company isn't discussing the Phase III timeline. But Soong says that they came out of Phase IIb with the belief that the high dose--to be tested at both 300 mg weekly and every other week in Phase III--would deliver the best results for patients. And there's nothing in the side effect profile that would require investigators to cut the dosing.

This data builds on earlier positive Phase IIb results for this drug.

The news out of Regeneron has been solid for several years now, helping make Yancopoulos the top-paid scientist in the industry. And his success has paid off for Sanofi, which came in as a development collaborator as well as a major stockholder. Leerink Swann analyst Joseph Schwartz has projected peak annual sales potential for dupilumab at $2.8 billion for two indications: asthma and atopic dermatitis. And the partners could be setting the stage for even more.

Special Report: Science pays: 2013's 10 best-compensated R&D chiefs in biopharma - George Yancopoulos, Regeneron

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