Arcutis to Highlight Data from Phase 3 Trials for Scalp and Body Psoriasis and Atopic Dermatitis at the 83rd American Academy of Dermatology Meeting

Rhea-AI Summary

Arcutis Biotherapeutics (ARQT) presented new data from Phase 3 trials at the 2025 American Academy of Dermatology Meeting, showcasing results for ZORYVE® treatments in psoriasis and atopic dermatitis (AD).

The INTEGUMENT 1-2 trials (n=1,337) demonstrated positive efficacy of ZORYVE cream 0.15% in AD patients with prior inadequate response to conventional treatments. Over 91% of participants reported no or mild application site sensation, and ≥97% showed no or minimal irritation.

The ARRECTOR trial revealed significant improvements in patient-reported outcomes for ZORYVE foam 0.3% in scalp and body psoriasis, showing enhanced quality of life across 23-component Scalpdex assessment during the eight-week study period.

• AD affects ~26 million adults and children in the US
• Psoriasis impacts ~9 million US adults and children, with over half experiencing scalp involvement

Positive

• Strong safety profile with >91% reporting no/mild application site effects
• Positive efficacy in patients resistant to conventional treatments
• Significant quality of life improvements in scalp psoriasis patients
• Large addressable market of 35M+ potential patients in the US

Negative

• None.

Insights

Clinical Researcher

The new Phase 3 data for Arcutis Biotherapeutics offers meaningful clinical insights for both ZORYVE cream and its investigational foam formulation. The INTEGUMENT trial data demonstrates ZORYVE cream 0.15% maintained strong efficacy in atopic dermatitis patients who previously failed other topical treatments – a particularly challenging population that represents a significant market opportunity.

Most impressively, over 91% of these difficult-to-treat patients reported no or mild sensations at application sites, with investigators noting minimal or no irritation in ≥97% of participants. This tolerability profile addresses a critical limitation of existing topicals, particularly corticosteroids, which often cause intolerable side effects with prolonged use.

The ARRECTOR trial data for the investigational ZORYVE foam 0.3% demonstrates significant improvements in quality-of-life metrics across the 23-component Scalpdex assessment. Scalp psoriasis has historically been underserved by existing treatments, as vehicle formulations struggle to effectively deliver medication through hair to affected areas.

This data strengthens Arcutis' position in the competitive dermatology space by showcasing efficacy in treatment-resistant populations while maintaining an excellent safety profile. The expansion into scalp applications could meaningfully expand ZORYVE's addressable market, particularly important given the high prevalence of scalp involvement in psoriasis patients.

Financial Analyst

Arcutis has strategically presented clinical data that strengthens its commercial positioning in the competitive dermatology market. The subgroup analysis from INTEGUMENT trials is particularly significant as it targets the estimated 60.8% of AD patients with inadequate response to topical corticosteroids – effectively positioning ZORYVE cream as an alternative in a substantial market segment.

The addressable market highlighted is substantial – 26 million Americans with atopic dermatitis and 9 million with psoriasis. The scalp psoriasis focus is commercially astute, with the company noting that more than half of psoriasis patients experience scalp involvement, an area notoriously difficult to treat with conventional formulations.

This data presentation strengthens Arcutis' differentiation against competitors by demonstrating efficacy in patient populations where current standard-of-care treatments have limitations. The foam formulation for scalp and body psoriasis addresses a significant treatment gap and could potentially expand the company's total addressable market if approved.

From a commercial perspective, this data helps build the clinical narrative supporting both the approved cream formulation and the investigational foam product, potentially strengthening physician adoption and payer positioning. The patient-reported outcomes data is particularly valuable for market access discussions with insurers, who increasingly require quality-of-life improvements in addition to clinical efficacy metrics.

• Data demonstrated favorable safety and local tolerability of ZORYVE^® (roflumilast) cream 0.15% in adults and children with atopic dermatitis (AD) with prior inadequate response, intolerance, and contraindications to topical treatments
• New patient reported outcome data for investigational ZORYVE^® (roflumilast) foam 0.3% demonstrated favorable efficacy, safety, and local tolerability data in scalp and body psoriasis
• In the United States, AD affects approximately 26 million adults and children and psoriasis affects approximately 9 million adults and children, with more than half experiencing involvement of the scalp

WESTLAKE VILLAGE, Calif. and ORLANDO, Fla., March 07, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new data from two posters shared at the 2025 American Academy of Dermatology Annual Meeting (AAD).

The first poster presentation details the positive efficacy, patient reported outcomes, and tolerability for the use of once-daily ZORYVE cream 0.15% in adults and children 6 years and older with mild to moderate AD from the INTEGUMENT 1-2 trials (n=1,337) who reported a prior inadequate response, intolerance or contraindication to topical corticosteroids (TCS; 60.8%), topical calcineurin inhibitors (TCI; 18.1%), or crisaborole (7.3%). At all timepoints assessed during the four-week trial, more than 91% of participants reported no or mild sensation at the application site and investigators reported no irritation or minimal erythema (redness) in ≥ 97% of participants in these subgroups. Improvement in AD was observed across multiple efficacy endpoints and safety was consistent with the overall study population.

A second poster presentation shares results from the Phase 3 ARRECTOR trial that outlines improvements in patient-reported outcomes with investigational ZORYVE foam 0.3% compared with vehicle in adults and children aged 12 or older with psoriasis of the scalp and body. ZORYVE foam significantly improved quality of life across the 23-component Scalpdex assessment throughout the eight-week study period. Individuals reported an improvement in symptoms as well as a reduction in how psoriasis impacted their daily life (e.g., embarrassment, stress, affecting clothing choices, or hair styles).

“While topical therapies are the first line of therapy for millions of people with atopic dermatitis, there are many who are contraindicated or have an inadequate or intolerant response to topical therapies, which have previously been considered the standard of care. These data add to the large body of evidence that highlights the effectiveness, safety, and tolerability of ZORYVE cream 0.15% across diverse patient types, making it a suitable targeted topical and alternative to steroids for adults and children with atopic dermatitis,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “In addition, the patient reported outcome data being shared at AAD underscores our team’s commitment to finding meaningful innovations for immuno-dermatologic conditions like psoriasis that can have a significant physical and emotional impact on the individuals that live with these chronic conditions and their caregivers.”

The posters will be available electronically during the meeting in the exhibition poster hall beginning Friday, March 7, 2025.

Pooled Safety and Local Tolerability of Roflumilast Cream 0.15% from the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Trials of Patients With Atopic Dermatitis: Subgroup Analysis of Patients With Prior Inadequate Response, Intolerance, and/or Contraindications to Topical Treatments
Simpson, E et al.
Poster Number 62155

Roflumilast Foam 0.3% in Patients With Scalp and Body Psoriasis: Improvements in Patient-Reported Outcomes (ARRECTOR)
Gooderham, M et al.
Poster Number 62151

About ZORYVE (roflumilast)
ZORYVE is a next generation topical PDE4 inhibitor. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. ZORYVE^® (roflumilast) cream 0.3% is approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. ZORYVE^® (roflumilast) cream 0.15% is approved by the FDA for the topical treatment of mild to moderate AD in patients 6 years of age and older. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Eczema Product.” ZORYVE ^® (roflumilast) cream 0.05% is under review for the treatment of AD in children ages 2 to 5 by the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025. Another formulation of ZORYVE, ZORYVE (roflumilast) topical foam, 0.3%, is indicated for treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. ZORYVE foam is under review for the treatment of scalp and body psoriasis by the FDA with a PDUFA target action date of May 22, 2025.

INDICATIONS
ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.

ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.

The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including three FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, AD, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on The Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential of ZORYVE foam and regulatory timing for FDA approval based on the PDUFA for the treatment of scalp and body psoriasis, the potential for clinical results for ZORYVE foam and ZORYVE cream to translate into real-world results, and the potential for ZORYVE cream and ZORYVE foam to advance the standard of care in AD, plaque psoriasis, and other inflammatory dermatological conditions. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com

Investors
Latha Vairavan, Vice President, Finance and Corporate Controller
ir@arcutis.com

FAQ

What were the key findings of ZORYVE cream 0.15% in the INTEGUMENT 1-2 trials for atopic dermatitis?

Over 91% of participants reported no/mild application site sensation, and ≥97% showed no/minimal irritation, with positive efficacy in patients who had inadequate response to previous treatments.

How did ARQT's ZORYVE foam 0.3% perform in the Phase 3 ARRECTOR trial for scalp psoriasis?

The trial showed significant improvements in quality of life across 23-component Scalpdex assessment, reducing symptoms and daily life impacts throughout the 8-week study period.

What is the market potential for ARQT's ZORYVE treatments based on patient population?

The treatments target a substantial market with 26 million AD patients and 9 million psoriasis patients in the US, with over half having scalp involvement.

What advantages does ZORYVE cream 0.15% offer over traditional topical treatments for atopic dermatitis?

It provides a suitable alternative to steroids with proven effectiveness and safety for patients who had inadequate response, intolerance, or contraindications to conventional topical treatments.