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2021-10-25| Trials & Approvals

Sanofi, Regeneron’s Dupixent Shines in Phase 3 Trial for Prurigo Nodularis

by Rajaneesh K. Gopinath
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Regeneron Pharmaceuticals, Inc. and Sanofi’s, Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. So far, the drug has notched FDA approvals for several indications, including Eczema, moderate-to-severe asthma, moderate-to-severe atopic dermatitis, and chronic rhinosinusitis with nasal polyposis.

On October 22nd, the companies announced that Dupixent met its primary and all key secondary endpoints in a pivotal Phase 3 trial for a new indication. Results show that the drug significantly reduced itch and skin lesions in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease that causes extreme itch and skin lesions.

“We are encouraged that patients in this trial experienced a significant reduction in itch and skin lesions, especially given that prior to enrollment nearly all patients had severe itch, and nearly 40% had 100 or more nodules covering their body,” said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi.

“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 program 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.”

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Prurigo Nodularis

People with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. It is often described as painful with burning, stinging, and tingling of the skin.

These severe symptoms can negatively affect a patient’s quality of life, including mental health, activities of daily living, and social interactions. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases with intense, chronic itch.

At present, there are no approved systemic treatments for this condition, and only high-potency topical steroids associated with long-term safety risks are available.

“Prurigo nodularis is an underdiagnosed disease with immense physical and emotional burden for the 74,000 people in the US who are unable to control their disease with topical steroids and otherwise do not have an approved treatment option. These patients are left to cope with severe itching and painful nodules that, in turn, significantly impair one’s quality of life with many resorting to immunosuppressants and some to antidepressants,” said George D. Yancopoulos, M.D., Ph.D., President and CSO at Regeneron.

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Phase3 PRIME2 Trial

The trial compared the performance of 78 patients treated with Dupixent to the 82 patients receiving placebo. Results showed that about 37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline compared to 22% of placebo patients (p=0.0216) at week 12, the primary endpoint.

At week 24, 58% of Dupixent patients compared to 20% of placebo patients (p<0.0001) experienced a clinically meaningful reduction in itch from baseline, which is almost a three-time difference. Also, these patients were nearly three times as likely to achieve clear or almost clear skin: 45% of Dupixent patients compared to 16% of placebo patients (p<0.0001) at week 24.

Dupixent patients experienced significantly greater improvements in measures of health-related quality of life, skin pain, and symptoms of anxiety and depression.

“These results show – for the first time in a Phase 3 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,” George D. Yancopoulos added.

Patients are fully enrolled for an additional trial called LIBERTY-PN PRIME, which has a similar trial design and is expected to read out in the first half of 2022. Sanofi and Regeneron plan to begin regulatory submissions in 2022.

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