Arcutis Announces Multiple Abstracts, Including Oral Presentation, Accepted at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference

Rhea-AI Summary

Arcutis Biotherapeutics (Nasdaq: ARQT) will present five abstracts at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference from June 8-10, 2024, in Chicago, IL. The presentations include new long-term safety and efficacy data of roflumilast cream 0.15% for mild to moderate atopic dermatitis in patients aged 6 and above. Preclinical data on ARQ-234, a CD200 receptor agonist for atopic dermatitis, will also be showcased. Additional presentations will cover the consistent tolerability profile of topical roflumilast in psoriasis, seborrheic dermatitis, and atopic dermatitis. The company aims to advance the standard of care for chronic, immune-mediated skin diseases.

Positive

• Presentation of new long-term safety and efficacy data for roflumilast cream 0.15% in mild to moderate atopic dermatitis.
• Preclinical data on ARQ-234, a CD200 receptor agonist, will be showcased.
• Consistent tolerability profile of topical roflumilast in various dermatological conditions will be presented.
• Inclusion of data from the INTEGUMENT program, highlighting roflumilast cream's efficacy for adults and children.

Negative

• No financial data or revenue projections were provided in the announcement.
• The focus on preclinical and early clinical data introduces uncertainty about long-term market impact.
• The efficacy and safety data are confined to specific patient demographics and conditions, limiting broader applicability.

• New long-term safety and efficacy data of investigational roflumilast cream 0.15% in mild to moderate atopic dermatitis will be presented in an oral session
  
• Preclinical data on ARQ-234, CD200R agonist, for the treatment of atopic dermatitis
• Additional presentation of the consistent tolerability profile of topical roflumilast in psoriasis, seborrheic dermatitis, and atopic dermatitis
  

WESTLAKE VILLAGE, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced that five abstracts will be presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference, which will take place in Chicago, IL from June 8-10, 2024. Among these presentations will be new long-term safety and efficacy data for roflumilast cream 0.15% in patients ≥6 years of age with mild to moderate atopic dermatitis, and an encore of preclinical data on ARQ-234, a CD200 receptor agonist the Company is investigating for atopic dermatitis.

In addition, the Company will present investigator- and patient-rated local tolerability data evaluating topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis.

“We are committed to providing therapeutic innovation and advancing the standard of care for those living with chronic, immune-mediated skin diseases and look forward to sharing these exciting scientific findings including data for roflumilast cream for adults and children with atopic dermatitis from our INTEGUMENT program,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis. “We also look forward to sharing preclinical data from our pipeline for ARQ-234, a biologic we are developing for the treatment of atopic dermatitis.”

Presentation details follow:

• Oral Poster Presentation
  Long-term Safety and Efficacy of Roflumilast Cream 0.15% in Adults and Children Aged ≥6 Years With Mild to Moderate Atopic Dermatitis:
  A 52-week, Phase 3, Open-Label Safety Trial
  Presenting Author: Melinda Gooderham, MD, FRCPC
  Time: June 10, 1:30 pm CT
  Abstract number: 634

The following posters will be electronically available for the entirety of the conference and online beginning Saturday, June 8, 2024 at 6:00 pm CT.

Pooled Efficacy, Patient-Reported Outcomes, and Safety of Roflumilast Cream 0.15% From the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Clinical Trials of Adults and Children With Atopic Dermatitis
Simpson, E et al.
ePoster 641

Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients 2 to 5 Years of Age with Mild to Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial
Eichenfield, L et al.
ePoster 639

ARQ-234: a high affinity CD200-Fc fusion protein for the treatment of atopic dermatitis
Sheridan, J et al.
ePoster 637

Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis
Bunick, C et al.
ePoster 640

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 two 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, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X.

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

ZORYVE foam, 0.3%, is indicated for 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 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 foam 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.

Forward-Looking Statements
Arcutis cautions you that 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 for topical roflumilast to advance the standard of care in 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 U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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

Investors
Latha Vairavan, Vice President, Finance and Investor Relations
lvairavan@arcutis.com

FAQ

What is ARQT presenting at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference?

ARQT is presenting five abstracts covering the long-term safety and efficacy of roflumilast cream 0.15% for atopic dermatitis, preclinical data on ARQ-234, and the tolerability of topical roflumilast in dermatological conditions.

When will ARQT present their new data at the conference?

ARQT will present their new data from June 8-10, 2024, at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference in Chicago, IL.

What is the focus of ARQT's new data presentation for roflumilast cream?

The focus is on the long-term safety and efficacy of roflumilast cream 0.15% for mild to moderate atopic dermatitis in patients aged 6 and above.

What is ARQ-234, and what is its relevance in ARQT's presentation?

ARQ-234 is a CD200 receptor agonist for the treatment of atopic dermatitis, and preclinical data on this biologic will be presented at the conference.

What additional data will ARQT present at the conference?

ARQT will also present data on the consistent tolerability profile of topical roflumilast in psoriasis, seborrheic dermatitis, and atopic dermatitis.