Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the enrollment of the last subject in its STRATUM phase 3 pivotal trial for topical roflumilast foam in patients with seborrheic dermatitis. If positive, the Company expects the study to be sufficient basis to submit a New Drug Application (NDA) in the United States in first half of 2023.
Roflumilast foam is a once-daily, topical formulation of a highly potent and selective PDE4 inhibitor (roflumilast). The foam formulation was designed to treat hair-bearing areas of the body, such as the scalp, and its use is being studied on all areas of the body, including the face.
“Individuals with seborrheic dermatitis have lacked new topical treatment options for decades, and current therapies leave much to be desired. The rapid enrollment of our Phase 3 trial highlights the need for topical treatments for seborrheic dermatitis that are suitable for all areas of the body, including the scalp and face,” said Patrick Burnett, MD, PhD, FAAD. “We are pleased to have completed enrollment in our pivotal Phase 3 study for roflumilast foam, marking another major milestone for our topical roflumilast clinical program. The STRATUM study was designed to generate robust safety, tolerability and efficacy data to support a potential regulatory filing.”
The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) is a Phase 3, parallel group, double blind, vehicle-controlled study of the safety and efficacy of roflumilast 0.3% foam administered once-daily. A total of 457 subjects ages nine and older with moderate to severe seborrheic dermatitis have been enrolled in the study. The primary endpoint of the study is the proportion of subjects achieving Investigator Global Assessment (IGA) success, defined as an IGA score of “clear” or “almost clear” plus a 2-point improvement at eight weeks. Top-line data results are expected in mid-year 2022. The Company announced in January 2021 that the U.S. Food and Drug Administration (FDA) had agreed that the single STRATUM study, if positive, would be sufficient basis for a New Drug Application in seborrheic dermatitis.
About Seborrheic Dermatitis
Seborrheic dermatitis affects more than 10 million people in the U.S., and is a common, chronic or recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often in areas of the body with oil-producing (sebaceous) glands, including the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back.
About Topical Roflumilast Foam
Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis. Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Arcutis has also filed a New Drug Application for a closely related cream formulation of topical roflumilast for the treatment of plaque psoriasis, with a Prescription Drug User Fee Act (PDUFA) action date of July 29, 2022. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators; it has been implicated in a wide range of inflammatory diseases including psoriasis, atopic dermatitis, 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 and the systemic treatment of plaque psoriasis.