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Arcutis' Roflumilast Foam Improves Scalp, Body Psoriasis As Early As Two Weeks After Treatment Initiation

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  • Arcutis Biotherapeutics Inc (NASDAQ: ARQT) has announced the presentation of new safety and efficacy data of roflumilast foam to treat scalp and body psoriasis.

  • Data were presented in a late-breaking oral presentation at the American Academy of Dermatology Virtual Meeting Experience.

  • New findings demonstrate that roflumilast foam significantly improved both scalp and body psoriasis, with improvement as early as two weeks after treatment initiation.

  • The primary endpoint of the clear or almost clear scalp at week eight was achieved by 59.1% of patients receiving roflumilast foam versus 11.4% of patients receiving vehicle.

  • 34.3% of roflumilast foam-treated and 3.4% of vehicle-treated patients rated clear at week eight.

  • Clear or almost clear on the body at week eight was achieved by 40.3% and 6.8% of patients receiving roflumilast foam and vehicle, respectively.

  • The most common treatment-related adverse events were application site pain (1.0% vs. 3.8%), diarrhea (1.5% vs. 0%), COVID-19 (1.5% vs. 1.9%), sinusitis (0.5% vs. 1.9%), psoriasis (0.5% vs. 1.9%), and hypertension (1.5% vs. 1.0%) for roflumilast foam and vehicle, respectively.

  • Discontinuation due to adverse events was 2.5% for roflumilast foam and 1.9% for the vehicle. In the study, no patients in either group experienced any serious adverse events.

  • Additionally, findings from Phase 2 study of Roflumilast Foam 0.3% in seborrheic dermatitis demonstrated roflumilast foam is a safe, well-tolerated, and effective treatment.

  • Treatment with roflumilast foam led to significant improvement in skin clearance and erythema and scaling individually and symptomatic improvement in itch in patients.

  • In the psoriasis Phase 2b study, roflumilast cream was well-tolerated. It provided significant improvements in investigator and patient‑assessed outcomes in participants with steroid-sensitive area involvement in a post-hoc analysis of the face, neck, or intertriginous areas in patients with chronic plaque psoriasis.

  • Roflumilast Cream and Foam are once-daily, topical formulations of a highly potent and selective PDE4 inhibitor.

  • Price Action: ARQT shares are down 3.4% at $29.53 in market trading hours on the last check Friday.

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