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Regeneron, Sanofi: Phase 3 Trial On Dupixent Met Key Endpoints At 24 Weeks

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi, on Thursday, announced that a pivotal Phase 3 trial evaluating Dupixent in patients with moderate-to-severe chronic spontaneous urticaria or CSU met its primary and all key secondary endpoints at 24 weeks.

Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naïve patients, compared to antihistamines alone in Study A, the first of two trials of the LIBERTY-CUPID clinical program.

"This is the first Phase 3 trial to show that by targeting IL-4 and IL-13, Dupixent can address the debilitating symptoms of chronic spontaneous urticaria like persistent itch and hives when standard-of-care antihistamines cannot sufficiently control the disease," said George Yancopoulos, President and Chief Scientific Officer at Regeneron.

Further, the companies expect to report results from a second trial in patients who were unable to control their chronic spontaneous urticaria with another biologic medicine, as well as other trial results in additional dermatologic diseases, by early 2022.

The trial demonstrated safety results similar to the known safety profile of Dupixent in its approved indications. For the 24-week treatment period, the occurrence of treatment emergent adverse events were generally similar between the Dupixent and placebo groups. The most common adverse events were injection site reactions.

The potential use of Dupixent in CSU and EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority, the company said.

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