TARRYTOWN, N.Y. and PARIS, Jan. 19, 2022 /PRNewswire/ --
Dupixent is the first and only medicine to demonstrate positive Phase 3 results in prurigo nodularis, confirming the potential benefit of targeting IL-4 and IL-13, central drivers of type 2 inflammation, to address itch and skin lesions
Data confirm results from first Phase 3 trial, with 60% of Dupixent patients meeting the primary endpoint of itch reduction compared to 18% of placebo patients at 24 weeks
Additionally, nearly three times as many Dupixent patients experienced reduced skin lesions
Data continue to support well-established safety profile of Dupixent
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive pivotal results from a second Phase 3 trial, PRIME, evaluating Dupixent® (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease. The trial met its primary and key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo at 24 weeks in this investigational setting. These data confirm the positive results that were previously reported from the Phase 3 PRIME2 trial, and are expected to be submitted to regulatory authorities around the world starting in the first half of this year.
"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," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "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 such as eosinophilic esophagitis."
People with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. Prurigo nodularis is often described as painful with burning, stinging and tingling of the skin. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch, and comparable to other debilitating chronic diseases that can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed, but are associated with safety risks if used long-term. There are approximately 75,000 people in the U.S. who are unable to control their disease with topical steroids and otherwise do not have an approved treatment option.
"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 unbearable itch, skin lesions, stinging and burning," says Naimish Patel, M.D, Head of Global Development, Immunology and Inflammation at Sanofi. "We are committed to researching the science behind type 2 inflammation to advance and shift perceptions in a number of inflammatory skin diseases that are not well-understood. The decision to accelerate directly into a Phase 3 clinical trial for prurigo nodularis was driven by our conviction that type 2 inflammation is a key driver of this highly pruritic disease and underscores our commitment to quickly bring novel treatments to patients who are in urgent need of new options."
In the Phase 3 PRIME trial, topline results comparing Dupixent (n=75) to placebo (n=76) showed at week 24:
- More than three times as many Dupixent patients experienced a clinically meaningful reduction in itch from baseline, the primary endpoint: 60% of Dupixent patients compared to 18% of placebo patients (p