ARQT - Arcutis gains as late-stage trial for atopic dermatitis therapy meets key goals

Arcutis Biotherapeutics ( NASDAQ: ARQT ) added ~6% pre-market Tuesday after announcing that its investigational therapy for atopic dermatitis (AD) roflumilast met the primary endpoint and all secondary endpoints in a pivotal Phase 3 trial.

The double-blind, vehicle-controlled trial named INTEGUMENT-1was designed to evaluate roflumilast cream 0.15% versus vehicle in 654 patients aged six years and older with mild to moderate AD.

Per the topline data, the study met the primary endpoint indicating that 32.0% of individuals who received roflumilast achieved Investigator Global Assessment (IGA) Success, a measure to assess AD severity at week four compared to 15.2% in the vehicle arm (P<0.0001).

The study also met all secondary endpoints with statistical significance, including that for Eczema Area and Severity Index (EASI-75) at week four which stood at 75% and 22.0% for those who received roflumilast and vehicle, respectively.

Despite several discontinuations due to adverse events, the study drug was well tolerated, the company said, adding that 93% of patients who received it completed the four weeks of the treatment.

Arcutis ( ARQT ) is running another pivotal Phase 3 trial for roflumilast called INTEGUMENT-2, which is expected to generate topline data by the year-end.

If positive, the company intends to submit a marketing application for the treatment in 2023 targeting mild to moderate AD in patients aged six years and older.

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