Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that detailed positive results from the Phase 3 PRIME2 trial evaluating the efficacy and safety of Dupixent (dupilumab) were presented in a late-breaking session at the American Academy of Dermatology (AAD) 2022 Annual Meeting. The companies previously announced topline results from PRIME2 and a second trial, called PRIME, investigating the use of Dupixent in adults with uncontrolled prurigo nodularis. In both trials, Dupixent significantly reduced itch and skin lesions compared to placebo. In total, 21 scientific abstracts evaluating the safety and efficacy of Dupixent in patients with atopic dermatitis in different age groups, as well as investigational indications of prurigo nodularis and chronic spontaneous urticaria will be presented at the congress.

'Prurigo nodularis is a relentless and often misunderstood itchy skin disease that leaves many patients with uncontrolled symptoms such as unbearable itch and painful skin lesions, along with a significantly impaired quality of life that should not be underestimated,' said Gil Yosipovitch, M.D., Professor of Dermatology at the Miller School of Medicine at University of Miami, Director of the Miami Itch Center and principal investigator of the trial. 'These positive results are the first time a Phase 3 trial has demonstrated that targeting key drivers of type 2 inflammation, IL-4 and IL-13, with dupilumab significantly improved itch and skin lesions in this highly burdensome disease.'

The randomized, placebo-controlled PRIME2 trial met its primary and all key secondary endpoints, with data presented at AAD 2022 showing: 37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline compared to 22% of placebo patients (p=0.0216) at week 12, the primary endpoint.

Nearly three times as many Dupixent patients experienced a clinically meaningful reduction in itch from baseline at week 24: 58% of Dupixent patients compared to 20% of placebo patients (p

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