- 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