Ever since phase 2 data were released in mid-2014, expectations have been high for Regeneron (REGN) and Sanofi’s (SNY) dupilumab, an injectable drug candidate for the treatment of atopic dermatitis (AD) and other inflammatory conditions. On Friday, the companies announced success in two phase 3 studies of the IL-4/IL-13 antibody in AD, and now plan to file for approval later this year with the FDA.
More important in the long run, Regeneron believes IL-4 and IL-13 inhibition, via dupilumab, could lead to success in other large inflammatory settings, like asthma. In a recent survey from Evercore ISI, investors pegged peak sales at around $4B (risk-adjusted) across all indications.
REGN climbed 4% with the news.
Over 1,300 patients with moderate-to-severe atopic dermatitis were enrolled in the identically-designed SOLO 1 and SOLO 2 trials and treated for 16 weeks with once weekly or once every two weeks dupilumab. Efficacy was measured by the 5-point Investigator’s Global Assessment (IGA) scale (the study’s primary endpoint), and the Eczema Area and Severity Index (EASI) served as a secondary measure of efficacy.
In SOLO 1 and 2 respectively, 37% and 36% of patients who received dupilumab 300mg weekly, and 38 and 36% of patients who received dupilumab 300mg every two weeks, achieved clearing or near-clearing of skin lesions (an IGA score of 0 or 1). That compared to 10 and 8.5% for placebo-treated patients (p <0.0001).
The improvement in EASI from baseline was 72 and 69% in patients who received the weekly dose, and 72 and 67% for the twice-monthly dose, compared to 38 and 31% for placebo (p <0.0001).
Atopic dermatitis is essentially a serious form of eczema. A chronic inflammatory disease, AD is characterized by itchy, inflamed skin that can lead to incessant scratching, open wounds, and infection. The physical manifestations can even lead to depression. For perspective, Forbes’ Matthew Herper spoke with a long-time sufferer of AD prior to the Regeneron data. Today, atopic dermatitis is mostly treated with topical products.
The U.S. FDA granted dupilumab Breakthrough Therapy designation in AD in November of 2014, shortly after the first successful phase 2 study in the indication.
