Arcutis' roflumilast clinches win in seborrheic dermatitis trial, proving it's no one trick pony in itch

Hot off its first approval this summer in psoriasis, Arcutis Biotherapeutics’ roflumilast foam 0.3%, approved in cream form under the brand name Zoryve, is out to prove it’s no one-trick pony in itch.

Friday, at the European Academy of Dermatology and Venereology 2022 congress, Arcutis drew the curtain back on late-stage roflumilast foam data in seborrheic dermatitis—a chronic inflammatory skin disease where the company is testing its drug in adults and kids ages nine years and up who have moderate-to-severe disease.

Armed with positive results from the late-stage STRATUM study, Arcutis aims to submit roflumilast foam for FDA approval in the first quarter of 2023, the company said in a release.

In the 457-subject trial, 80.1% of patients on roflumilast foam achieved investigator global assessment (IGA) success, which was defined as an IGA score of clear or almost clear, plus a level grade 2 or greater improvement from baseline on the same metric, which allowed the study to hit its primary endpoint. For comparison, just 59.2% of patients given a placebo cream were able to clinch success on the same measure.

Arcutis’ trial measured IGA scores across five severity grades, according to ClinicalTrials.gov. Those are clear (0), almost clear (1), mild (2), moderate (3) and severe (4).

Arcutis estimates there are more than 10 million people in the U.S. with seborrheic dermatitis, which causes red patches on the skin covered with “large, greasy, flaking yellow-gray scales and persistent itch,” the company explained in a release. The disease most often affects parts of the body with oil-producing glands, such as the scalp, face, upper chest and back.

STRATUM also showed that roflumilast foam charted statistically significant results on a host of secondary endpoints including itch reduction, plus achievement of an erythema—or skin redness—score of 0 and more at the eight-week mark.

Roflumilast's latest trial win comes shortly after the drug’s first FDA approval in a cream format for plaque psoriasis, including in skin folds known as intertriginous areas. The green light covers patients ages 12 years and up and all stages of the disease from mild to severe without any limitations on duration of use. Arcutis launched Zoryve in August.

Arcutis has said it’s set a wholesale acquisition cost of $825 per 60g tube, which is much cheaper than the $1,325 per tube list price of Dermavant’s recently approved psoriasis cream Vtama or the $1,950 sticker on Incyte’s topical eczema med Opzelura.

Across multiple indications, roflumilast could generate sales between $1.8 billion to $3.8 billion in 2030, Mizuho analysts have predicted.

Editor's note: This story has been updated to clarify that STRATUM looked at roflumilast foam, rather than Zoryve, which is a cream formulation of the same active ingredient.