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Arcutis Announces Inclusion of Children in On-going Pivotal Phase 3 Clinical Trials Evaluating Topical Roflumilast (ARQ-151) as a Potential Once Daily Topical Treatment for Plaque Psoriasis
FDA requests study amendment to allow inclusion of children ages 2 to 11 years in the DERMIS-1 and DERMIS-2 trialsStrong safety profile supported population
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"FDA requests study amendment to allow inclusion of children ages 2 to 11 years in the DERMIS-1 and DERMIS-2 trialsStrong safety profile supported population expansion in pivotal Phase 3 trialsTopical Roflumilast potential “Best in Class” topical PDE4 inhibitorPhase 3 trials’ topline data anticipated first half 2021 WESTLAKE VILLAGE, Calif., March 16, 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, at the request of the U.S. Food and Drug Administration (FDA), Arcutis has submitted a protocol amendment to the FDA to include children ages 2 to 11 years old in the Company’s on-going DERMIS-1 and DERMIS-2 pivotal Phase 3 clinical trials evaluating topical roflumilast cream as a potential topical treatment for plaque psoriasis. The trials’ previous inclusion criteria included patients ages 12 and above.\n “After consultations with the FDA, we are delighted that the Agency requested expanding the inclusion criteria to include children as young as two years of age in our pivotal Phase 3 clinical trials in patients with plaque psoriasis,” said Howard Welgus, MD, Chief Medical Officer at Arcutis. “Many treatment options approved for adults for this chronic skin condition have not been studied in children, a population where additional caution regarding safety and tolerability is paramount. As no cure for psoriasis exists, patients and dermatologists need new and better topical treatment options to manage this chronic inflammatory condition. Based on its safety, tolerability and efficacy profile in our completed clinical trials, we believe topical roflumilast has the potential to be both the best-in-class topical PDE4 inhibitor and the only topical PDE4 inhibitor approved for plaque psoriasis, including in children.\" Topical roflumilast cream (ARQ-151) contains the highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor roflumilast, which was approved globally for the systemic treatment of chronic obstructive pulmonary disease (COPD) in 2011, and has shown greater potency based on IC50 values (a non-clinical measure of a drug's potency) than other PDE4 inhibitors. PDE4 is an intracellular enzy...