Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: REGN) have announced data from the second Phase 3 trial of Dupixent (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease.
- The trial met its primary and key secondary endpoints, showing it significantly reduced itch and skin lesions compared to placebo at 24 weeks.
- The data confirm the positive results that were previously reported from the Phase 3 PRIME2 trial and will be submitted to regulatory authorities starting in 1H of 2022
- In Phase 3 PRIME trial, topline results comparing Dupixent (n=75) to placebo (n=76) showed that more than three times as many Dupixent patients experienced a clinically meaningful reduction in itch from baseline (60% vs. 18%).
- Nearly three times as many Dupixent patients achieved clear or almost clear skin, a secondary endpoint (48% vs. 18%).
- Overall rates of treatment-emergent adverse events were 71% for Dupixent and 63% for placebo.
- Price Action: SNY shares are down 0.69% at $51.81 during the premarket session on the last check Wednesday, and REGN stock closed at $611.22 on Tuesday.
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