Arcutis is advancing topical roflumilast foam (ARQ-154) into Phase 3 development for the treatment of seborrheic dermatitis

Roughly a week after announcing plans to initiate Phase 3 clinical trials for topical roflumilast cream (ARQ-151) in the treatment of atopic dermatitis (AD),  Arcutis Biotherapeutics, Inc. is now doing the same for topical roflumilast foam (ARQ-154) for seborrheic dermatitis following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). 

Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor. The Phase 3 program will consist of a single pivotal trial, which the Company anticipates initiating in the second or third quarter of 2021. 

“Following our interactions with the FDA, we are delighted to advance topical roflumilast foam into Phase 3 development for the treatment of seborrheic dermatitis, a disease that affects more than 10 million people in the U.S.,” says Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer, in a news release. “Results from our Phase 2 clinical trials with once-a-day topical roflumilast foam demonstrated that it provides statistically significant improvements in signs and symptoms of both seborrheic dermatitis and scalp psoriasis compared to a matching vehicle foam, while also being well tolerated. Unlike creams and ointments, roflumilast foam is suitable for use in hair-bearing areas; unlike steroids, it is expected to be suitable for long-term use, including on the face; and unlike shampoos, it is an elegant, quick drying, leave-in foam that doesn’t need to be rinsed out. If successful in the Phase 3 clinical trial and approved for commercialization, roflumilast foam has the potential to become the standard of care in seborrheic dermatitis.”

“Patients are desperate to find new treatment options for seborrheic dermatitis, a common, chronic skin disease affecting the face and scalp that can profoundly affect patients’ appearance and quality of life,” says Matthew Zirwas, M.D., Founder of Bexley Dermatology Research Clinic and an investigator in the trial. “Dermatologists and patients face a real challenge, with current treatment options that are either safe or effective, but rarely both. Based on clinical results to date, topical roflumilast has shown to be safe and effective, rapidly improving both the appearance and the itch, dramatically improving patients’ quality of life. Notably, it comes in a cosmetically elegant foam that can be used chronically in multiple locations without the burning and stinging associated with other treatment options. If approved, topical roflumilast will be a revolutionary advancement in the treatment of seborrheic dermatitis.”

In a recently completed Phase 2 study of roflumilast foam in seborrheic dermatitis, roflumilast foam demonstrated statistically significant improvement over the vehicle foam on the trial’s primary endpoint, Investigator Global Assessment (IGA) success, and multiple secondary endpoints including the reduction of itch. Once-daily roflumilast foam also demonstrated a favorable safety and tolerability profile. Additionally, other than a very small change in the formulation, roflumilast foam is identical to roflumilast cream (ARQ-151), Arcutis’ investigational topical cream PDE4 inhibitor, which has demonstrated symptomatic improvement and a favorable tolerability profile in clinical trials in plaque psoriasis, including chronic treatment of psoriasis, as well as encouraging results in atopic dermatitis.

Arcutis is currently conducting a Phase 2 long-term safety study in seborrheic dermatitis. This is a multicenter, open-label study of roflumilast foam 0.3% applied once daily in adolescent and adult patients with seborrheic dermatitis and includes patients who were treated previously in the Phase 2 trial, as well as patients naïve to treatment with topical roflumilast foam. Periodic clinic visits include assessments for clinical safety, application site reactions, and disease improvement, or progression.