Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi SA (SNY) are celebrating the success of their Phase 3 LIBERTY-CUPID Study C for Dupixent (dupilumab) in treating chronic spontaneous urticaria (CSU). This study, along with the previously completed Study A, demonstrated the effectiveness of Dupixent in controlling CSU, a debilitating skin condition characterized by hives and persistent itching.
The LIBERTY-CUPID Study C met both its primary and key secondary endpoints, confirming the results seen in Study A. This success comes after Dupixent received approval and was launched in Japan earlier this year for CSU in adults and adolescents. The study showed significant improvement in itch severity and urticaria activity in patients receiving Dupixent compared to those receiving a placebo. A notable 30% of Dupixent-treated patients reported a complete disappearance of urticaria, compared to only 18% of placebo recipients.
Beyond CSU, Regeneron and Sanofi are also celebrating the success of their Phase 2/3 ADEPT trial for Dupixent in the treatment of bullous pemphigoid, another chronic skin condition. The trial met its primary and all key secondary endpoints, demonstrating a significant improvement in sustained disease remission for Dupixent-treated patients compared to placebo. A remarkable five times more Dupixent patients achieved sustained remission than those receiving placebo. This success is attributed to Dupixent’s ability to effectively control the inflammation associated with these conditions.
While a separate Phase 3 trial (Study A) for Dupixent in adults with severe chronic pruritus of unknown origin (CPUO) did not achieve statistical significance in its primary endpoint, it still showed promising results in other itch-related measurements. This led Regeneron and Sanofi to plan Study B, a subsequent pivotal trial, to further investigate Dupixent’s potential for CPUO treatment.
These encouraging results for Dupixent further solidify its potential as a valuable treatment option for a range of chronic skin conditions. As the company prepares to submit detailed results from the LIBERTY-CUPID Study C to the FDA by the end of 2024, Dupixent’s future in the treatment of chronic skin conditions looks bright.
