Sanofi and partner Regeneron Pharmaceuticals will be encouraged by positive proof-of-concept data from Phase Ib trials assessing their antibody dupilumab in atopic dermatitis (AD).
Pooled data from two Phase Ib trials with dupilumab (REGN668/SAR231893), presented at the 71st Annual Meeting of the American Academy of Dermatology in Miami over the weekend, showed that treatment with four weekly subcutaneous injections of the drug - at either 150mg or 300mg per week - significantly improved the signs and symptoms of moderate-to-severe AD.
Patients whose disease was not adequately controlled with topical medications treated with dupilumab had significant improvements in body surface area (BSA) score, Investigator Global Assessment (IGA) score, and Eczema Area Severity Index (EASI) from baseline to week four compared to placebo, effects which were maintained at week eight in the 300mg dose group, the firms noted.
In addition, a responder analysis showed that, at week four, 54.5% of patients given the 150mg dose and 71.4% on the 300mg dose achieved a reduction in EASI score of 50% or greater compared to 18.8% with placebo.
On the safety side, the most common adverse events observed were nasopharyngitis (19.6% compared to 12.5% for the placebo arm) and headache (11.8% vs 6.3%, respectively).
AD is a chronic, immune-mediated, inflammation of the skin thought to affect between 1% and 3% of adults. For many patients, topical therapies are not effective for keeping the disease under control and the only approved systemic therapies to treat AD are prednisone and cyclosporine (in Europe), the companies note, highlighting the room for additional treatments for the condition.
"Despite existing therapies, a significant proportion of patients with moderate-to-severe atopic dermatitis continue to suffer from inflamed skin and intractable itch, which significantly impacts their quality of life,” commented the principal study investigator Eric Simpson, Associate Professor, Director of Clinical Studies, at Oregon Health and Science University.
“The early phase results with this biologic therapy, which has a novel mechanism of action, are encouraging to those of us who treat these patients and warrant further clinical investigation,” he added.
Dupilumab, which was created using Regeneron’s pioneering VelocImmune technology for producing fully human monoclonal antibodies, is currently being assessed in both atopic dermatitis and asthma as a subcutaneous injection.