Arcutis' Flagship Psoriasis Treatment Shows Sustained Efficacy, Clearance For Median Of 10 Months

Arcutis Biotherapeutics Inc ARQT announced new safety and efficacy durability data from its open-label Phase 2 long-term safety study of roflumilast cream (0.3%) in adults with chronic plaque psoriasis.
Roflumilast cream 0.3% (Zoryve) is a once-daily steroid-free topical phosphodiesterase-4 inhibitor approved by the FDA in July 2022.
The study showed that during the trial, 57.1% (n=185) of roflumilast cream-treated patients achieved an Investigator Global Assessment (IGA) score of clear or almost clear (IGA 0/1) at any time.
The participants had a median duration of IGA of clear or almost clear of more than ten months (40.1 weeks).
IGA success was achieved by 35.3% of participants previously treated with roflumilast cream and 37.5% of roflumilast-naïve participants. IGA success was defined as clear/almost clear plus 2-grade improvement from baseline.
42% of participants previously treated with roflumilast cream and 47.5% of roflumilast-naïve participants achieved an IGA score of clear or almost clear (IGA 0/1) at Week 52.
66.7% of participants in Cohort-21 achieved Intertriginous-IGA (I-IGA) success, defined as clear or almost clear plus 2-grade improvement from baseline.
No tachyphylaxis occurred, and efficacy was consistent over time among participants who achieved an IGA of clear or almost clear.
Safety data showed low discontinuation rates due to AEs, and ≥97% of patients showed no irritation.
Price Action: ARQT shares closed higher by 2.24% at $14.12 on Friday.
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