Arcutis Biotherapeutics Inc. (ARQT) Begins Phase 3 Clinical Trial of Topical Roflumilast Cream (ARQ-151)

April 12, 2021 9:38 AM EDT

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Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced it initiated a pivotal Phase 3 clinical trial evaluating topical roflumilast cream (ARQ-151) as a potential treatment for mild-to-moderate atopic dermatitis (AD) in patients between the ages of 2 and 5 years old. Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is developing for plaque psoriasis and AD.

“Young children suffering from atopic dermatitis often struggle with intense, persistent itching that can lead to damage caused by scratching, and that can negatively impact quality of life for both the child and the caregiver,” said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer. “Since the majority of atopic dermatitis patients are children, safety is particularly important. We are pleased to initiate this pivotal Phase 3 trial because we believe topical roflumilast has the potential to eliminate the need to compromise between safety, tolerability, and efficacy. In clinical trials, roflumilast cream has demonstrated a favorable safety and tolerability profile, and importantly, unlike steroids, it is safe to use chronically. In a previous Phase 2 trial, topical roflumilast has also shown encouraging efficacy in adult patients with atopic dermatitis. If approved, roflumilast cream may offer an additional treatment option to physicians and parents with otherwise limited choices.”

The “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients” (or INTEGUMENT-PED) is a Phase 3, parallel group, double blind, vehicle-controlled trial in which roflumilast cream 0.05% or vehicle is applied once daily for 4 weeks to patients between the ages of 2 and 5 years old with mild-to-moderate AD involving ≥3% body surface area (excluding the scalp, palms, soles).

In the trial, approximately 650 subjects will be randomized 2:1 to either roflumilast cream 0.05% or matching vehicle cream. The primary endpoint of the trial is Investigator Global Assessment (IGA) Success, defined as a Validated Investigator Global Assessment - Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4. Multiple secondary endpoints will also be evaluated, including itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) as well as the proportion of subjects who attain at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 4. The Company anticipates topline data from INTEGUMENT-PED in the second half of 2022.

Arcutis recently initiated two other pivotal Phase 3 trials (INTEGUMENT-1 and -2), which are identical Phase 3, parallel group, double blind, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle is applied once daily for 4 weeks to subjects 6 years of age and older with mild to moderate AD involving ≥3% body surface area.

About Atopic DermatitisAtopic dermatitis (AD) is the most common type of eczema, occurring in approximately 6% of the U.S. population. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms and legs, and the rash can cover significant areas of the body, in some cases half of the body or more. Disease onset is most common by 5 years of age, and the Company estimates that approximately 60% of patients suffering from AD are pediatric patients. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Given that most of the patients are pediatric, the safety and tolerability of AD therapies is paramount.

About Topical Roflumilast CreamRoflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

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