Arcutis to Present New Roflumilast Cream Phase 3 Data at The European Academy of Dermatology and Venereology (EADV) Spring Symposium
Presentation will highlight efficacy and safety data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential topical once-daily treatment for chronic plaque psoriasis
WESTLAKE VILLAGE, Calif., May 03, 2021 (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, will present efficacy and safety data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential once-daily topical treatment for chronic plaque psoriasis at the European Academy of Dermatology and Venereology (EADV) Spring Symposium May 6 - May 7, 2021.
“The EADV symposium is an important and respected venue for exchanging information on the latest research and innovations in the field of dermatology,” said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer, Arcutis. “We are thrilled the pivotal phase 3 data for roflumilast cream in the treatment of chronic plaque psoriasis has been accepted in the program as an oral presentation and look forward to sharing the findings with the dermatology community. We are also delighted that Dr. Mark Lebwohl, who participated in the study and is one of the world’s leading authorities on psoriasis, will present the studies’ results.”
The “Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS” One and Two (or DERMIS-1 and DERMIS-2) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or matching vehicle cream were 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 was IGA Success at week 8. Multiple secondary endpoints were also evaluated, including I-IGA Success, and improvements in Psoriasis Area Severity Index (PASI), itch as measured by the WI-NRS and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD).
Details of Arcutis’ EADV Spring Symposium presentation is as follows:
Roflumilast is a highly potent phosphodiesterase-4 (PDE4) inhibitor in development for plaque psoriasis (PsO). Arcutis is investigating roflumilast as a once-daily, nonsteroidal, topical treatment for plaque psoriasis, atopic dermatitis, seborrheic dermatitis, and scalp psoriasis.
Scalp psoriasis is a manifestation of plaque psoriasis characterized by plaques in the hair-bearing area of the scalp and sometimes extending to the forehead, back of the neck, or behind or inside the ears. Patients with scalp psoriasis commonly have plaques on other areas of the body as well. Scalp psoriasis is present in nearly half of Americans with psoriasis. As with psoriatic plaques on other parts of the body, scalp psoriasis is often itchy and sometimes painful. It can also be associated with hair loss.
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