Regeneron Pharmaceuticals Inc. (NASDAQ: REGN), in conjunction with Sanofi, released top-line results for its most recent late-stage study. The companies announced that two placebo-controlled Phase 3 studies evaluating investigational dupilumab in adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD) met their primary endpoints.
Overall, in the studies, treatment with dupilumab as monotherapy significantly improved measures of overall disease severity, skin clearing, itching, quality of life and mental health.
Back in November 2014, the U.S. Food and Drug Administration (FDA) granted dupilumab Breakthrough Therapy designation in AD. Dupilumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.
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George D. Yancopoulos, M.D., Ph.D., chief scientific officer of Regeneron and president of Regeneron Laboratories, commented:
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. Dupilumab is the first in a new class of immunotherapies – in these 16 week trials, dupilumab blocked the aberrant activation of this pathway, resulting in significant efficacy without evidence of immune-suppressing side effects. We continue to evaluate the role of IL-4 and IL-13 signaling in related inflammatory conditions, including asthma and nasal polyposis, where we have ongoing dupilumab clinical development.
Following the release, shares of Regeneron traded up nearly 3% to $370.83 early Friday, with a consensus analyst price target of $485.32 and a 52-week trading range of $348.96 to $605.93.
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