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Biotech / Medical : Regeneron Pharmaceuticals
REGN 761.58+0.8%Nov 24 3:59 PM EST

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From: Julius Wong6/6/2016 7:56:20 PM
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Regeneron and Sanofi's dupilumab successful in late-stage atopic dermatitis study
  • A Phase 3 clinical trial, LIBERTY AD CHRONOS, assessing dupilumab, a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13 signaling, for the treatment of adults with moderate-to-severe atopic dermatitis (AD) met its primary and key secondary endpoints. The 740-subject study compared the safety and efficacy of dupilumab together with topical corticosteroids (TCS) to TCS alone in adult patients with AD who were inadequately controlled with TCS with or without calcineurin inhibitors.
  • 39% of patients who received either 300 mg of dupilumab once weekly or every two weeks with TCS achieved clearing or near-clearing of skin lesions compared to 12% for placebo plus TCS (p<0.0001) as measured by a metric called Investigator's Global Assessment (IGA).
  • 64% of the patients treated with 300 mg of dupilumab weekly achieved a 75% reduction in eczema severity while 69% of the patients on the two-week interval achieved it. Both handily beat placebo + TCS's 23% (p<0.0001).
  • The rate of adverse events (AEs) was comparable between the test and control groups. The most common dupilumab-related AEs were injection site reactions.
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