Sanofi and Regeneron’s monoclonal antibody (mAb) Dupixent (dupilumab) met all primary and key secondary endpoints in a Phase III trail for the chronic inflammatory skin disease prurigo nodularis.
Dupixent significantly reduced itch and skin lesions compared to placebo in the investigational trial setting.
Specifically, 37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline, compared to 22% of placebo patients.
Meanwhile, nearly three times as many Dupixent patients experienced a clinically meaningful reduction in itch from baseline at week 24 (58% of Dupixent patients compared to 20% of placebo patients).
Patients treated with Sanofi’s biologic therapy also experienced ‘significantly greater improvements’ across a number of health-related quality of life measures, as well as skin pain and anxiety and depression symptoms.
“These data are an important step forward in furthering our knowledge of the role that targeting IL-4 and IL-13 can play in the treatment of skin diseases that cause extreme itch. We are committed to continuing to leverage the robust Dupixent clinical programme to transform the understanding of the science behind a number of type 2 inflammatory diseases and look forward to presenting the full results at a future medical congress,” said John Reed, global head of Research and Development at Sanofi.
Individuals living with prurigo nodularis experience symptoms including intense and persistence itch with thick skin lesions – nodules – that can cover most of the body.
There are currently no approved systemic treatments for the condition – high-potency topical steroids are often used which are associated with safety risks if used long-term, Sanofi said in a statement.
“These results show – for the first time in a Phase III prurigo nodularis trial – that a systemic medicine is able to address the most debilitating symptoms such as itch without broadly suppressing the immune system, building on the promise of Dupixent in a broad range of serious dermatologic, respiratory and gastrointestinal diseases,” said George D. Yancopoulos, president and chief scientific officer at Regeneron.
