Benzinga | May 3, 2021 04:40PM EDT

Arcutis Biotherapeutics To Present New Roflumilast Cream Phase 3 Data At The European Academy of Dermatology and Venereology Spring Symposium May 6-7, 2021

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:

* Free Communications (FC01.04): Roflumilast cream, a once-daily, potent phosphodiesterase-4 inhibitor, in chronic plaque psoriasis patients: Efficacy and safety from DERMIS-1 and DERMIS-2 Phase 3 trials Date: May 6, 2021 Time: 14:30 -- 14:40 CEST Presenter: Mark Lebwohl, M.D. Professor and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai

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.

For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter. Join the conversation with the hashtag #EADVSymposium.