Business
Arcutis Announces Positive Topline Results from Pivotal DERMIS-1 and -2 Phase 3 Trials of Topical Roflumilast Cream (ARQ-151) in Plaque Psoriasis
Roflumilast cream demonstrated statistically significant superiority over vehicle on primary endpoint of IGA SuccessFavorable safety and tolerability profile
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Roflumilast cream demonstrated statistically significant superiority over vehicle on primary endpoint of IGA SuccessFavorable safety and tolerability profile in this patient populationNew Drug Application (NDA) submission anticipated in the second half of 2021Roflumilast cream potential “Best in Class” topical PDE4 inhibitor, a non-steroidal treatment intended for chronic usePlaque psoriasis affects approximately 8.6 million patients in the U.S.Company to host a conference call today at 8:30 a.m. EST WESTLAKE VILLAGE, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced positive topline results from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential topical treatment for plaque psoriasis. Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4). On the studies’ primary endpoint of Investigator Global Assessment (IGA) Success at week 8, roflumilast cream 0.3% had an ‘IGA Success’ rate in DERMIS-1 of 42.4% compared to a vehicle rate of 6.1% (P","length":2392,"tagName":"div"}]