Meiji Seika Pharma’s Morcamilast (ME3183) was Granted Orphan Medicinal Product Designation by the European Commission for Palmoplantar Pustulosis

Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, President and Representative Director: Toshiaki Nagasato) today announced that morcamilast (proposed international nonproprietary name; development code: ME3183), a selective phosphodiesterase-4 (PDE4) inhibitor, has been granted orphan medicinal product designation by the European Commission (EC) for the treatment of palmoplantar pustulosis (PPP).

Palmoplantar pustulosis is a chronic inflammatory disease characterized by the development of multiple sterile pustules on the palms and soles. Patients often experience pain and pruritus of the skin, and the condition can be accompanied by nail involvement and joint pain. Because lesions on the palms are visible to others and lesions on the soles can cause pain while walking, daily functioning can be significantly restricted, leading in a substantial reduction in quality of life. PPP has a pathophysiology distinct from psoriasis and pustular psoriasis, and treatment can be challenging, underscoring the need for new treatment options.

Morcamilast is an orally available, novel, selective PDE4 inhibitor discovered by Meiji Seika Pharma. In non-clinical pharmacology studies, it demonstrated higher anti-inflammatory activity than approved PDE4 inhibitors, including approximately 30-fold greater inhibition of TNF-α production, while exhibiting low brain distribution. In addition, a clinical study in patients with psoriasis vulgaris has suggested high therapeutic efficacy, supporting the potential of morcamilast as a new treatment option for inflammatory diseases. The results of this study were published in the dermatology journal Journal of the European Academy of Dermatology and Venereology (https://doi.org/10.1111/jdv.20863).

In addition to plaque psoriasis, Meiji Seika Pharma will explore development and commercialization opportunities, including potential partnerships, to make morcamilast available to patients with PPP as early as possible.

Meiji Seika Pharma is advancing morcamilast for autoimmune diseases with high unmet medical needs and remains committed to delivering safe and effective treatments to patients as quickly as possible.

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