Sanofi/Regeneron Discontinue Dupixent Phase 3 Trial in Chronic Spontaneous Urticaria Due to Futility

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Today, Regeneron and Sanofi announced that the Phase 3 trial (CUPID STUDY B) evaluating Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU) will be stopped due to futility based on a pre-specified interim analysis.

According to reports, in this trial, although numerical improvements were observed in the key endpoint, Dupixent did not reach statistical significance in the interim analysis conducted by the independent review committee.

Previously reported Phase 3 trial evaluated patients who were biologic-naïve (i.e., previously untreated with Omalizumab) across different groups, achieving both the primary and all key secondary endpoints at 24 weeks. The trial demonstrated that adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives compared to antihistamines alone.

CSU is a chronic inflammatory skin disease characterized by the sudden appearance of hives or deep subcutaneous swelling on the skin. Dupixent, developed using Regeneron's VelocImmune platform, is the first fully human antibody targeting IL-4Rα and is currently co-marketed by Sanofi and Regeneron. The drug selectively inhibits the key interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways, reducing pathological responses of type 2 inflammation and treating type 2 inflammation-related diseases such as asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and atopic dermatitis through its mechanism.

The two companies said that they plan to use Dupixent for CSU patients who are not controlled by antihistamines and are evaluating the next steps.

Dupixent was first approved by the U.S. FDA in March 2017 for adult patients with moderate-to-severe atopic dermatitis whose condition is not adequately controlled by topical prescription medications or who are not suitable for these treatments. On June 19, 2020, the drug was approved for marketing in China. Currently, the drug has been approved in approximately 50 countries and regions worldwide. Earlier this month, Regeneron and Sanofi announced that the U.S. FDA had granted priority review status to the supplemental Biologics License Application (sBLA) for Dupixent as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.

Reference Source: Regeneron, Sanofi To Stop Dupixent Phase 3 Trial In Chronic Spontaneous Urticaria Due To Futility