Arcutis to Present Data Fom Topical Roflumilast Clinical Program at EADV 2022 Congress

Arcutis to present data from topical roflumilast clinical program at EADV 2022 Congress.

Arcutis Biotherapeutics, Inc. will present 4 abstracts for its topical roflumilast program in seborrheic dermatitis and psoriasis at the 31st European Academy of Dermatology and Venerology (EADV) Congress in Milan, virtually and in-person. In these abstracts, new data, including safety, efficacy, and tolerability in treating sensitive areas will be announced.

The topical cream and foam formulations of roflumilast are being developed as a once-daily, nonsteroidal, topical treatment for several dermatologic conditions. The highly potent and selective phosphodiesterase-4 (PDE4) inhibitor is an intracellular enzyme that increases the production of pro-inflammatory mediators. Roflumilast cream 0.3% (ZORYVE) was approved by the US Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis in patients 12 years of age and older.

The oral presentation of the phase 3 pivotal trial of roflumilast foam in seborrheic dermatitis includes:

  • Efficacy and safety of roflumilast foam 0.3% in patients with seborrheic dermatitis in a phase 3 trial
  • Efficacy and safety by race and ethnicity in a random, double-blind, vehicle-controlled phase 2a study evaluating once-daily roflumilast foam 0.3% in patients with seborrheic dermatitis
  • Long-term study and efficacy of roflumilast foam 0.3% in patients with seborrheic dermatitis in a 24-52-week, open-label phase 2 trial
  • Efficacy and tolerability of roflumilast cream 0.3% in patients with chronic plaque psoriasis involvement on the face, intertriginous, or genital areas: Pooled results from phase 3 trials (DERMIS-1 and DERMIS-2)

The 2022 EADV Congress includes over 600 presenters and over 170 sessions.2

References:

  1. New Data from Arcutis’ Topical Roflumilast Clinical Program Presented at the European Academy of Dermatology and Venereology (EADV) Congress. GlobeNewswire News Room. Published September 6, 2022. Accessed September 6, 2022. https://www.globenewswire.com/news-release/2022/09/06/2510355/0/en/New-Data-from-Arcutis-Topical-Roflumilast-Clinical-Program-Presented-at-the-European-Academy-of Dermatology-and-Venereology-EADV-Congress.html
  2. EADV. European Academy of Dermatology and Venereology. Accessed August 30, 2022. https://www.eadv.org/