Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) and Sanofi have announced encouraging pivotal findings from the second phase three study, PRIME, evaluating Dupixent in adults with uncontrolled prurigo nodularis, an acute type 2 inflammatory skin disorder.
PRIME study met primary and secondary endpoints
The study met its primary and secondary goals, demonstrating that Dupixent significantly decreased itching and skin lesions in the experimental environment after 24 weeks when compared with placebo. These findings back up the favorable results from the third Phase PRIME2 study and will be presented to regulatory agencies worldwide in 1H 2022.
Chief scientific officer and president George Yancopoulos said, “Prurigo nodularis is a highly burdensome disease involving dozens, if not hundreds of incessantly itchy and burning skin lesions, and the potential for complications such as skin infections. The results of this trial once again show that Dupixent is able to significantly address the hallmark symptoms of this disease while maintaining a consistent safety profile, including a numerically lower rate of skin infections. We are encouraged by the progress of our extensive Dupixent development program that continually reinforces IL-4 and IL-13 as key drivers of the type 2 inflammation underlying a number of diseases, including dermatological diseases such as prurigo nodularis and atopic dermatitis, respiratory diseases such as asthma and chronic rhinosinusitis with nasal polyps, and gastrointestinal diseases.”
Prurigo nodularis causes skin itiching and lessions
Prurigo nodularis causes strong, continuous itching and dense skin lesions (known as nodules), which can cover the majority of the body. It is a painful skin infection that causes stinging, burning, and tingling. Due to the intense itch, unmanaged prurigo nodularis has one of the biggest impacts on life quality in inflammatory skin disorders and is equivalent to other severe chronic conditions which can negatively impact mental health, everyday activities, and social contacts.
Sanofi, head of global development, immunology, and inflammation Naimish Patel, said, “These results strengthen our understanding of the underlying biology of prurigo nodularis and are encouraging as we seek to help patients severely impacted by symptoms like an unbearable itch, skin lesions, stinging and burning.”
