Roflumilast foam useful in patients with moderate to severe seborrheic dermatitis, reveals phase 3 trial

WESTLAKE VILLAGE, Calif: Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced positive topline results from the STRATUM pivotal Phase 3 trial investigating roflumilast foam as a potential treatment for adolescents and adults with moderate to severe seborrheic dermatitis. Roflumilast foam 0.3%, an investigational once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor being developed to treat inflammatory dermatoses, particularly in hair-bearing areas of the body such as the scalp, demonstrated significant improvements based on IGA Success and other endpoints.

The study met the primary endpoint with 80.1% of individuals treated with roflumilast foam achieving 'IGA Success' compared to 59.2% of patients treated with vehicle (P<0.0001) at week eight. IGA Success was defined as an IGA score of clear or almost clear plus a ≥2 grade improvement from baseline.

Improvement with roflumilast foam was seen early, with roflumilast separating statistically from vehicle on IGA Success at week two. In addition, more than 50% of patients treated with roflumilast foam achieved an IGA score of clear at week eight. Roflumilast foam also demonstrated statistically significant improvements compared to vehicle on key secondary endpoints, including itch, scaling, and redness (erythema).

"Despite the prevalence and impact on quality of life of seborrheic dermatitis, there remains significant unmet need for new options to treat this condition, with individuals today left to manage their symptoms with multiple treatments and complex application routines," said Dr. Zoe Draelos, study investigator, dermatologist in High Point, North Carolina, and President, Dermatology Consulting Services, PLLC. "As both a trial investigator and a clinician, I am excited by these results because they demonstrate the potential for roflumilast foam to be a well-tolerated, easy-to-use, steroid-free treatment option for adults and adolescents with moderate to severe seborrheic dermatitis."

Roflumilast foam was well-tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. There were no treatment-related Serious Adverse Events (SAEs).

Overall, the most common adverse events in the study population (over 1%) included COVID-19, urinary tract infection, nasopharyngitis, and nausea. Over 90% of patients who were randomized to roflumilast foam in the study completed the full eight weeks, and there were few discontinuations due to adverse events (0.7% and 2.0% in the roflumilast foam and vehicle groups, respectively).

"We are excited that investigational roflumilast foam demonstrated strong topline results in our pivotal Phase 3 trial, consistent with previously reported data. These results move us one step closer to providing a new treatment option for the millions of people suffering from seborrheic dermatitis," said Patrick Burnett MD, PhD, FAAD, Chief Medical Officer at Arcutis. "We will now prepare an NDA for roflumilast foam for the treatment of seborrheic dermatitis to submit to the U.S. Food and Drug Administration (FDA)."

Arcutis announced in January 2021 that, based on feedback received from the FDA, the Company believes the single STRATUM study, if positive, would be sufficient basis for an NDA for roflumilast foam in dermatitis. Arcutis plans to submit an NDA in the first half of 2023. If roflumilast foam is approved by the FDA, the Company plans to leverage its existing commercial infrastructure to bring the product to market.

Management will host a conference call today at 8:30 a.m. EDT to discuss these results. To access the call, please dial (833) 614-1393 (domestic) or (914) 987-7114 (international) and provide the conference ID# 7384524. A live webcast of the call will also be available on the "Events" section of the Company's Investor website. An archived replay of the webcast will be available on the Arcutis website following the call.