Sanofi and Regeneron’s Dupixent shows promising results in Phase 3 eczema trial

Sanofi and Regeneron Pharmaceuticals have achieved a significant milestone with their jointly developed eczema drug, Dupixent (dupilumab), meeting the primary endpoints in a year-long Phase 3 clinical trial for adults with uncontrolled moderate-to-severe atopic dermatitis (AD).

Breakthrough in Atopic Dermatitis Treatment

The CHRONOS trial, a critical phase 3 study, involved Dupixent administered alongside topical corticosteroids (TCS) and compared its efficacy to monotherapy using TCS alone. Results showed that the combination significantly eased the severity of the disease more than TCS alone, marking a significant advancement in the treatment of this chronic inflammatory skin condition.

Andrew Blauvelt, M.D., President of Oregon Medical Research Center and principal investigator of the CHRONOS trial, highlighted the impact of the findings: “These new results build upon previous positive Phase 3 monotherapy data. In the CHRONOS study, Dupixent used with topical corticosteroids showed significantly greater clearance of skin lesions and overall disease severity compared to topical corticosteroids alone.”

Clinical Trial Insights

The trial prominently featured patients whose disease was not manageable by topical medications alone. The phase 3 trial demonstrated that at 16 weeks and one year, Dupixent with TCS substantially reduced overall disease severity compared to placebo with TCS. Specifically, at 16 weeks, 39% of patients receiving Dupixent achieved clear or almost clear skin, compared to only 12% of those receiving placebo.

Moreover, a significant percentage of patients treated with Dupixent achieved EASI-75, indicating a 75% reduction in the Eczema Area and Severity Index, a measure of the severity of eczema. These results were notably higher than those in the placebo group.

Regulatory Milestones and Future Prospects

Dupixent has been accepted for FDA priority review, with a decision expected by March 29. This follows its FDA Breakthrough Therapy designation received in 2014 for moderate to severe atopic dermatitis. Additionally, the European Medicines Agency (EMA) is reviewing the Marketing Authorization Application for Dupixent.

The success of Dupixent in clinical trials underscores its potential as a transformative treatment for atopic dermatitis. By effectively addressing the inflammation that drives AD, Dupixent not only improves skin health but also enhances the overall quality of life for patients suffering from this debilitating condition.

As atopic dermatitis is a chronic disease requiring long-term management, the availability of Dupixent could represent a significant shift in how this condition is treated, offering hope to millions who have struggled with inadequate treatment options.