Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) revealed on Wednesday that their ADEPT study on Dupixent (dupilumab) for bullous pemphigoid (BP) met both its primary and all key secondary endpoints in evaluating its investigational use in adults with moderate-to-severe cases. This study aims to support global regulatory submissions, commencing with the United States later this year. If approved, Dupixent would become the first targeted medication available for BP treatment in both the U.S. and the European Union.
The companies also reported that a smaller, separate Phase 3 study, known as Study A, assessing Dupixent's investigational use in adults with uncontrolled severe chronic pruritus of unknown origin (CPUO), did not achieve statistical significance in its primary endpoint focused on an itch responder. However, it did show nominally significant improvements across other itch endpoints.
BP is a chronic, relapsing condition marked by intense itching, blisters, skin reddening, and painful lesions. Dupixent has emerged as the first and only biologic to achieve significant improvements in both disease remission and symptom management in pivotal BP studies. The U.S. Food and Drug Administration (FDA) has previously granted Dupixent Orphan Drug Designation for BP.
The ADEPT study involved 106 adults with moderate-to-severe BP, randomized to receive either Dupixent 300 mg bi-weekly following an initial loading dose or a placebo, along with standard-of-care oral corticosteroids (OCS). Results showed that patients on Dupixent were five times more likely to achieve sustained disease remission compared to those on placebo. Specifically, 20% of Dupixent patients experienced sustained disease remission at 36 weeks, compared to just 4% of those on placebo.
George Yancopoulos, Board Co-Chair, President, and Chief Scientific Officer at Regeneron, stated, "Bullous pemphigoid is a debilitating skin disorder with a high risk of mortality due to infection. Dupixent is the first medication to demonstrate substantial and robust efficacy in this patient group. These latest pivotal outcomes further confirm the key role that type-2 inflammation plays in multiple skin diseases."
The safety and efficacy of Dupixent for both BP and CPUO are still under clinical investigation and have not yet been sanctioned by any regulatory authority.
Dupixent has already received regulatory approval in over 60 countries for various indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease across different age groups.
