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Arcutis Announces Enrollment of First Patient in Topical Roflumilast Cream Phase 3 Open Label Extension Study in Plaque Psoriasis

  • Topical Roflumilast Cream (ARQ-151) Potential “Best in Class” Topical PDE4 inhibitor
  • Roflumilast Cream Potentially Only Topical PDE4 inhibitor for Psoriasis
  • Open Label Extension Study to Support Potential Recommendations for Long-term Use of Roflumilast Cream

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 mediators, 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)
Up to 250 subjects who completed 8 weeks of the double-blind treatment in the company’s Phase 3 DERMIS-1 or DERMIS-2 studies are eligible to roll over to the DERMIS-OLE open label extension study. In this study, all subjects will receive 0.3% topical roflumilast cream for 24 weeks. The primary endpoints of this study will be the occurrence of Treatment-Emergent Adverse Events (TEAEs) and the occurrence of Serious Adverse Events (SAEs).

Phase 3 Program: ARQ-151-301 (DERMIS-1) and ARQ-151-302 (DERMIS-2)
Arcutis is currently conducting a Phase 3 clinical program with topical roflumilast cream, including two ongoing Phase 3 clinical trials (Studies ARQ-151-301 and ARQ-151-302) to support registration with the FDA. The studies, referred to as the “Trials of PDE4 inhibition with Roflumilast for the Management of Plaque Psoriais” (DERMIS-1, DERMIS-2), are identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which 0.3% topical roflumilast cream or vehicle cream are applied once daily for 8 weeks to subjects aged 12 and above with mild, moderate or severe chronic plaque psoriasis involving between 2% and 20% body surface area. The studies will each enroll approximately 400 patients. The primary endpoint of the studies is Investigator Global Assessment (IGA) Success, defined as an IGA score of clear or almost clear and at least a 2-grade improvement from baseline at week 8 on the IGA score. Multiple secondary endpoints will also be evaluated, including Intertriginous IGA (I-IGA) Success, and improvements in Psoriasis Area Severity Index (PASI), itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). The company anticipates topline data from the Phase 3 studies in the first half of 2021.

About Psoriasis
Psoriasis is an immune disease that occurs in about two percent of adults in western countries.  About 90% of psoriasis cases is plaque psoriasis, which is characterized by “plaques”, or raised, red areas of skin covered with a silver or white layer of scale.  Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and the plaques are often itchy and sometimes painful.  Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous areas (where two skin areas may touch or rub together).

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 or follow the Company on LinkedIn.

John W. Smither
Chief Financial Officer

Investors and Media:
Derek Cole, President
Investor Relations Advisory Solutions

A photo accompanying this announcement is available at 

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