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Arcutis Announces Last Patient Completes Final Study Visit in DERMIS-1 and DERMIS-2 Pivotal Phase 3 Clinical Trials Evaluating ARQ-151 (Topical Roflumilast Cream) as a Potential Treatment for Plaque Psoriasis

Nachrichtenquelle: globenewswire
07.12.2020, 15:00  |  107   |   |   

  • Phase 3 trials’ topline data anticipated in the first quarter of 2021 and potential New Drug Application (NDA) submission anticipated by the end of 2021
  • Roflumilast cream potential “Best in Class” topical PDE4 inhibitor
  • Plaque psoriasis affects approximately 8.6 million patients in the U.S.

WESTLAKE VILLAGE, Calif., Dec. 07, 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 that the last participant has completed the 8-week treatment period in DERMIS-1 and DERMIS-2, the Company’s pivotal Phase 3 clinical trials evaluating ARQ-151 (topical roflumilast cream) as a potential topical treatment for plaque psoriasis.

“Plaque psoriasis affects approximately 8.6 million patients in the U.S., many of whom are desperate for new topical options that don’t require them to make trade-offs,” said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer. “We are delighted to complete DERMIS-1 and DERMIS-2, our pivotal phase 3 clinical trials evaluating roflumilast cream as a potential once daily topical treatment for plaque psoriasis. If approved, we believe roflumilast cream has the potential to eliminate the need for dermatologists and patients to compromise between efficacy and safety. We anticipate announcing topline data from these trials in the first quarter of 2021 and, if positive, anticipate submission of our NDA to the FDA by the end of 2021. We are immensely grateful to the trial participants and the clinical investigators for their time and commitment to this important research effort.”

Arcutis recently announced positive results from its Phase 2 long-term safety study in plaque psoriasis, which support chronic use of roflumilast cream. In addition, The New England Journal of Medicine published results from the double-blind, randomized Phase 2b study of roflumilast cream in plaque psoriasis.

The “Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS” One and Two (or DERMIS-1 and DERMIS-2) are identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or vehicle cream are applied once daily for 8 weeks to subjects age 2 years and above with mild, moderate or severe chronic plaque psoriasis involving between 2% and 20% body surface area. DERMIS-1 enrolled 439 subjects, and DERMIS-2 enrolled 442 subjects. 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 quarter of 2021 and, if positive, anticipates submission of its NDA to the FDA by the end of 2021.

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Arcutis Announces Last Patient Completes Final Study Visit in DERMIS-1 and DERMIS-2 Pivotal Phase 3 Clinical Trials Evaluating ARQ-151 (Topical Roflumilast Cream) as a Potential Treatment for Plaque Psoriasis Phase 3 trials’ topline data anticipated in the first quarter of 2021 and potential New Drug Application (NDA) submission anticipated by the end of 2021Roflumilast cream potential “Best in Class” topical PDE4 inhibitorPlaque psoriasis affects …

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