Clinical Development

Topical roflumilast foam (ARQ-154) is a foam formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011.  Roflumilast has shown greater potency based on IC50 values (a non-clinical measure of a drug’s potency) than any other disclosed PDE4 inhibitor.  PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD.  PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

Arcutis believes that topical roflumilast also has the potential to address the significant need for a new standard of care in seborrheic dermatitis – a condition that has seen no substantial treatment advances in over two decades, and where current topical treatments frequently fail or pose safety concerns that limit their use. Topical roflumilast foam is nearly identical to topical roflumilast cream, Arcutis’ investigational topical cream PDE4 inhibitor that has demonstrated symptomatic improvement and a favorable tolerability profile based on the Company’s clinical trials in plaque psoriasis.  Based on the profile of topical roflumilast foam and prior clinical data with topical roflumilast cream, Arcutis is advancing its evaluation in seborrheic dermatitis into Phase 3 development, anticipating initiation of a single pivotal Phase 3 study (STRATUM) in the second or third quarter of 2021, with topline data anticipated in the second or third quarter of 2022.

Arcutis also believes roflumilast foam has significant potential as a scalp psoriasis treatment.  Topical roflumilast cream, nearly identical to the foam formulation, has demonstrated statistically significant improvements of psoriasis symptoms and a favorable tolerability profile in two separate Phase 2 studies.  Psoriasis plaques on the scalp are identical to plaques elsewhere on the body, so the roflumilast cream psoriasis results should be highly predictive.  Arcutis reported positive topline data from Phase 2b study in patients with scalp and body psoriasis which affects more than 2.5
million of the 6 million psoriasis patients in U.S with active disease.  Pending discussions with regulators, the Company expects to initiate its Phase 3 program in scalp psoriasis in the second half of 2021, with topline data anticipated in the second half of 2022.