Regeneron-Sanofi's Dupixent Significantly Improved Signs, Symptoms In Chronic Itchy Skin Disease

Regeneron Pharmaceuticals Inc REGN and Sanofi SA SNY have presented detailed results from the Phase 3 PRIME2 trial of Dupixent (dupilumab) 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. 
• Prurigo nodularis is often described as painful with burning, stinging, and tingling of the skin. People experience intense, persistent itch with thick skin lesions (called nodules). 
• The PRIME2 trial met its primary and all key secondary endpoints.
• 37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline compared to 22% of placebo patients 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% vs. 20%).
• Nearly three times as many Dupixent patients achieved clear or almost clear skin at week 24: 45% of Dupixent patients compared to 16% of placebo patients.
• Related: Sanofi - Regeneron's Dupixent Under FDA Priority Review For Children Under 5 Years With Atopic Dermatitis.
• Results from the confirmatory PRIME trial will be presented at an upcoming medical congress. 
• The companies plan to file regulatory submissions for Dupixent in prurigo nodularis in 1H of 2022.
• Price Action: REGN shares closed 0.04% at $680.03 and SNY stock closed 0.66% higher at $51.53 on Friday.