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Data from Long-Term Safety Study Support Chronic Use of ARQ-151 (Topical Roflumilast Cream) as a Potential Treatment for Plaque Psoriasis
Once-daily roflumilast cream demonstrated favorable safety and tolerability over 52 to 64 weeks of treatmentAt 52 to 64 weeks of treatment, over one-third of
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Once-daily roflumilast cream demonstrated favorable safety and tolerability over 52 to 64 weeks of treatmentAt 52 to 64 weeks of treatment, over one-third of subjects demonstrated IGA Success and 45% of subjects had attained an IGA of clear or almost clearData further support the potential of roflumilast cream as a novel, once-daily, chronic topical treatment for plaque psoriasis, including intertriginous psoriasisPivotal Phase 3 data in plaque psoriasis are anticipated in first quarter of 2021 WESTLAKE VILLAGE, Calif., Dec. 01, 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 positive results for the Phase 2 long-term safety study evaluating ARQ-151 (topical roflumilast cream) 0.3% as a potential once-daily chronic topical treatment for plaque psoriasis.\n The long-term safety study enrolled 332 patients, including one cohort (Cohort 1) of patients who elected to continue open-label treatment (n=230) following their participation in the double-blind, randomized Phase 2b study of roflumilast cream in plaque psoriasis, the results from which were published in the New England Journal of Medicine, and second cohort (Cohort 2) of treatment naïve patients (n=102). The maximum duration of treatment ranged from 52 weeks for naïve patients and those treated with vehicle in the randomized Phase 2b study, to 64 weeks for those treated with roflumilast cream for 12 weeks in the randomized Phase 2b study. In this open-label study, roflumilast cream 0.3% applied once daily for up to 52 weeks demonstrated favorable safety and tolerability over the long-term treatment period, consistent with what was seen in the randomized Phase 2b study, with only 3.6% of patients experiencing a treatment-related adverse event during 52 weeks of treatment. At week 52 of the long-term safety study, 44.8% of all subjects attained an Investigator Global Assessment (IGA) of clear or almost clear, with 34.8% of subjects in Cohort 1 and 39.5% of subjects in Cohort 2 achieving IGA Success, defined as a score of clear or almost clear plus a two-grade improvement from baseline. Additionally, of the subjects in the 12 week randomized Phase 2b st...