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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