Injectable eczema drug dupilumab meets primary endpoints in two phase 3 studies

The drug, dupilumab, improved rash, itching and other symptoms of AD, which is a severe form of eczema.

The SOLO1 and SOLO2 studies met their primary endpoints in improving measures of overall disease severity, skin clearing, itching, quality of life and mental health.

The trials included 1,379 adult patients with moderate-to-severe atopic dermatitis whose symptoms were not adequately controlled with topical medications.

Patients were randomly assigned to dupilumab 300 mg subcutaneously once weekly or every two weeks, or placebo, for 16 weeks after an initial dupilumab loading dose of 600 mg or placebo.

Results showed that 37% of patients in SOLO1 and 36% of patients in SOLO2 who received dupilumab 300 mg weekly, and 38% of patients in SOLO1 and 36% of those in SOLO2 who received dupilumab 300 mg every 2 weeks, had clearing or near-clearing of skin lesions, the primary endpoint.

Lesions cleared or nearly cleared in 10% of patients in SOLO1 and 8.5% of patients in SOLO2 who received placebo.

Regeneron chief scientific officer and Regeneron Laboratories president George Yancopoulos said: "These are the first Phase 3 studies of a systemic therapy to demonstrate a significant improvement in moderate-to-severe atopic dermatitis, a chronic, debilitating inflammatory disease that impacts over one million Americans.

"These data provide strong evidence that the IL-4 and IL-13 signaling pathway is a fundamental driver of inflammation in atopic dermatitis."

Regeneron and Sanofi said they will continue to assess the role of IL-4 and IL-13 signaling in related inflammatory conditions, including asthma and nasal polyposis, where there is ongoing dupilumab clinical development.

The companies plan to file the drug in the US in the third quarter of this year.