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 Success
  
• Favorable safety and tolerability profile in this patient population
• New Drug Application (NDA) submission anticipated in the second half of 2021
• Roflumilast cream potential “Best in Class” topical PDE4 inhibitor, a non-steroidal treatment intended for chronic use
• Plaque 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<0.0001), and in DERMIS-2 an ‘IGA Success’ rate of 37.5% compared to a vehicle rate of 6.9% (P<0.0001). IGA Success was defined as an IGA score of clear or almost clear and at least a 2-grade improvement from baseline. Roflumilast cream 0.3% also demonstrated statistically significant improvements over vehicle on key secondary endpoints, including on Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD).

In DERMIS-1 and DERMIS-2, roflumilast cream was generally safe and well-tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate in severity. Overall, 90% of patients who were randomized to roflumilast cream in the studies completed the full 8 weeks. Among subjects receiving roflumilast cream, there were only 5 discontinuations in DERMIS-1 due to a TEAE (1.7% of subjects) and 1 discontinution in DERMIS-2 due to TEAE (0.3% of subjects), and there were no treatment-related Serious Adverse Events (SAEs).