Positive Topline Results from Pivotal Phase 3 Trial of Arcutis Biotherapeutics' Roflumilast Foam in Scalp and Body Psoriasis

Topline results from the ARRECTOR Pivotal Phase 3 trial evaluating Arcutis Biotherapeutics, Inc.'s roflumilast foam 0.3% were positive for the treatment of adults and adolescents with scalp and body psoriasis. The study met its co-primary endpoints of S-IGA Success and B-IGA Success, and all secondary endpoints.

Specifically, 67.3% of individuals treated with roflumilast foam, a once-daily, non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor, achieved S-IGA Success compared to 28.1% of individuals treated with a matching vehicle foam at week 8 (P<0.0001), and 46.5% of individuals treated with roflumilast foam achieved B-IGA Success compared to 20.8% of individuals treated with a matching vehicle foam at week 8 (P<0.0001). Roflumilast foam also demonstrated statistically significant improvements compared to vehicle on all secondary endpoints, including scalp itch as measured by Scalp Itch Numeric Rating Scale (SI-NRS) and overall itch as measured by Worst Itch NRS (WI-NRS) at week eight.

Plaque psoriasis impacts 9 million people in the United States and approximately 40% of individuals have involvement of the scalp. Scalp psoriasis can have a significant negative impact on quality of life, with individuals feeling shame, embarrassment, or self-consciousness as a result of their scalp disease. Today, scalp psoriasis is most often treated with topical therapies, including corticosteroids and vitamin D analogs, which come with trade-offs between efficacy, tolerability, and long-term usability. Roflumilast foam is a selective and potent PDE4 inhibitor that has been uniquely formulated as an emollient, water-based, moisturizing foam that can be used on the scalp and body.

“Topical therapies are first-line treatments for scalp and body psoriasis, but current options have limitations including aesthetic acceptability, tolerability, effectiveness, and limited duration of use, which can lead to poor outcomes and significantly impact patients’ quality of life. Roflumilast foam provided significant clearance with a rapid onset of action on both the scalp and body as measured by S-IGA and B-IGA respectively,” says Melinda Gooderham, MSc, MD, FRCPC, Medical Director, SKiN Centre for Dermatology, investigator with Probity Medical Research, and study author, in a news release. “These data demonstrate that investigational roflumilast foam, if approved, could provide both an effective and well-tolerated new treatment option for scalp and body psoriasis.”

Roflumilast foam was well-tolerated, and the overall safety and tolerability profile was consistent with previously published studies of roflumilast cream 0.3% and foam. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and generally similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. Overall, the most common adverse events in the study population included headache, diarrhea, and COVID-19. In the study, 89.0% of patients who were randomized to roflumilast foam completed the full eight weeks, and few subjects discontinued study drug due to adverse events (2.5% and 1.3% in the roflumilast foam and vehicle groups, respectively).

“We are excited to share these topline results of roflumilast foam, a once-daily non-steroidal treatment option that was designed to overcome limitations of traditional creams and ointments for hair-bearing areas of the body. These pivotal Phase 3 results demonstrate the strong efficacy and tolerability of roflumilast foam for the treatment of scalp and body psoriasis and, with the recently announced Phase 3 results in seborrheic dermatitis, the overall potential for roflumilast foam for the treatment of these skin diseases,” adds Patrick Burnett, MD, PhD, FAAD. Chief Medical Officer at Arcutis. “The successive positive results from two pivotal Phase 3 programs for roflumilast foam in two different indications just this year highlights the unique formulation and deep dermatological expertise Arcutis brings to solve unmet needs in medical dermatology.”

The Company already announced plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast foam for the treatment of seborrheic dermatitis in Q1 of 2023. The Company believes that the positive results from the ARRECTOR study should provide sufficient bases for a supplemental NDA.