ARQT - Arcutis says second Phase 3 trial for atopic dermatitis therapy reached main goal

Arcutis Biotherapeutics ( NASDAQ: ARQT ) announced Monday that its investigational topical formulation roflumilast cream achieved the primary endpoint in the second pivotal Phase 3 trial for atopic dermatitis (AD). Arcutis ( ARQT ) fell ~5% shortly after the company shares resumed for trading after a brief trading halt.

The INTEGUMENT-2 was a double-blind, vehicle-controlled trial that involved 683 patients aged six years and older with mild to moderate AD who received ro?umilast cream 0.15% or vehicle once daily for four weeks.

According to topline data, the trial met the primary endpoint with ~29% of patients who received ro?umilast achieving Investigator Global Assessment (IGA) Success, a clinical measure of the disease, compared to 12.0% in the vehicle group (P<0.0001).

INTEGUMENT-2 also achieved key secondary endpoints, including ~42% of patients in the ro?umilast arm reaching a 75% improvement of Eczema Area and Severity Index (EASI-75) at week four compared to ~20% of patients treated with the vehicle (P<0.0001).

In terms of safety, the drug was well tolerated leading to a low incidence of treatment emergent adverse events (TRAEs) which were mostly mild to moderate severity.

While more than 90% in the ro?umilast arm completed the full four weeks of the therapy, there were ~2% and ~1% discontinuations due to adverse events in the roflumilast cream and vehicle groups, respectively

AD is the most prevalent form of eczema, impacting nearly 9.6M children and 16.5M adults in the U.S.

The company intends to seek FDA authorization for ro?umilast cream 0.15% for the treatment of patients aged six years and above with mild to moderate AD, with the filing of a supplemental new drug application ((sNDA)) expected in H2 2023.

Arcutis ( ARQT ) is enrolling patients aged 2 to 5 years with mild to moderate AD in a third pivotal Phase 3 trial for ro?umilast cream 0.15%, which is on track to generate topline data next year.

In November, the company said the experimental therapy's first pivotal Phase 3 trial met the primary endpoint and all secondary endpoints in mild to moderate AD.

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