New data from STRATUM pivotal phase III trial of roflumilast foam 0.3% in seborrheic dermatitis presented at European Academy of Dermatology and Venereology Congress.- Arcutis Biotherapeutics

Roflumilast foam 0.3% is 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.

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 geater than 2 grade improvement from baseline. improvement with roflumilast foam was seen early, with roflumilast separating statistically from vehicle on iga success at week two, the first timepoint assessed.></0.0001)>

Roflumilast foam also demonstrated statistically significant improvements compared to vehicle on all secondary endpoints in the trial, including itch, scaling, and erythema (redness). i.More than 60% of individuals with a Worst Itch-Numerical Rating Score (WI-NRS) of 4 or higher at baseline treated with roflumilast foam achieved a greater than 4-point reduction in itch at Week 8. (63.6% with roflumilast foam vs 42.3% vehicle (P=0.0002)). ii. More than 50% of individuals treated with roflumilast foam achieved an erythema score of 0 at week 8. (57.9% with roflumilast foam vs 32.7% vehicle (P<0.0001)). iii. more than 50% of individuals treated with roflumilast foam achieved a scaling score of 0 at week 8. (58.2% with roflumilast foam vs 37.5% vehicle (p="0.0001))."></0.0001)).>

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). Roflumilast foam demonstrated favorable local tolerability with no evidence of irritation in >98% of patients as assessed by the investigator and no or mild sensations in reported by greater than 92% across all timepoints and treatment groups.

Arcutis plans to submit an NDA for roflumilast foam for the treatment of seborrheic dermatitis to the FDA in the first quarter of 2023.

About STRATUM : The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) is a Phase III, parallel group, double blind, vehicle-controlled study of the safety and efficacy of roflumilast foam 0.3% administered once-daily. A total of 457 subjects ages nine years and older with moderate to severe seborrheic dermatitis were enrolled in the study and were randomized 2:1 roflumilast foam to vehicle. The primary endpoint of the study was the proportion of subjects achieving IGA Success, defined as an IGA score of clear or almost clear plus a greater than 2 grade improvement at week 8.