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Arcutis Announces Enrollment of First Patient in Topical Roflumilast Cream Phase 3 Open Label Extension Study in Plaque Psoriasis
??WESTLAKE VILLAGE, Calif., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced it has enrolled the first patient in an open label extension study, DERMIS-OLE, evaluating topical roflumilast cream (ARQ-151) as a potential treatment for plaque psoriasis. Roflumilast cream, Arcutis’ lead product candidate, is a highly potent and selective phosphodiesterase type 4 inhibitor (“PDE4 inhibitor”) once-daily topical cream. Howard Welgus, M.D., Arcutis’ Chief Medical Officer, commented: “Psoriasis can be difficult to treat with topical agents, which are often limited by inadequate efficacy, poor safety and tolerability, or both. In clinical trials, topical roflumilast cream has demonstrated an efficacy and tolerability profile that may offer meaningful improvements over existing topical treatments to patients with plaque psoriasis. We are conducting a Phase 3 program with roflumilast cream, including two registrational Phase 3 studies in plaque psoriasis called DERMIS-1 and DERMIS-2, and intend to use the results from the DERMIS open label extension study to support potential recommendations for long-term use of roflumilast cream in patients with this chronic disease. We believe roflumilast cream has the potential to be a once daily treatment that benefits patients with plaque psoriasis who currently lack suitable treatment options.” Topical roflumilast cream (ARQ-151) contains the highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor roflumilast, which has been approved globally for the systemic treatment of chronic obstructive pulmonary disease (COPD) since 2011 and which is many-fold more potent than any other disclosed PDE4 inhibitor. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory meditors, and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of atopic dermatitis and the systemic treatment of plaque psoriasis. DERMIS-OLE Open Label Extension Study (ARQ-151-306) Phase 3 Program: ARQ-151-301 (DERMIS-1) and ARQ-151-302 (DERMIS-2) About Psoriasis About Arcutis - Bioscience, applied to the skin. Arcutis is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. Arcutis exploits recent innovations in inflammation and immunology to develop potential best-in-class therapies against validated biological targets, leveraging our deep development, formulation and commercialization expertise to bring to market novel dermatology treatments, while maximizing our probability of technical success and financial resources. Arcutis is currently developing three novel compounds (topical roflumilast cream (ARQ-151), topical roflumilast foam (ARQ-154) and ARQ-252) for multiple indications, including psoriasis, atopic dermatitis, seborrheic dermatitis and eczema. For more information, please visit www.arcutis.com or follow the Company on LinkedIn. Contact: Investors and Media: A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4aafa010-32a2-4c34-9b65-3d49e478e752 |