Regeneron, Sanofi’s Dupilumab Shines in Phase 3

Regeneron and Sanofi’s immunotherapy dupilumab has met primary endpoints in a Phase 3 trial in patients with uncontrolled moderate-to-severe atopic dermatitis.

The LIBERTY AD SOLO 1 and SOLO 2 trials showed that monotherapy treatment with dupilumab substantially improved measures of overall disease severity, skin clearing, itching, quality of life and mental health.

Dupilumab blocks the irregular activation of the IL-4 and IL-13 signaling pathway, which stimulates inflammation in atopic dermatitis. The FDA granted the candidate breakthrough therapy designation in November 2014. The companies plan to submit the NDA in the third quarter.