News Release Details

• Data highlight potential of roflumilast cream as a “Best in Class” topical PDE4 inhibitor for the treatment of atopic dermatitis and plaque psoriasis
• Two oral presentations and one poster at the European Academy of Dermatology and Venereology Virtual Congress
• Data to also be featured in poster sessions at the Society of Dermatology Physician Assistants Digital 2020 and 2020 Fall Clinical Dermatology Conferences
  

WESTLAKE VILLAGE, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- 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 will present new data from the previously announced Phase 2 studies of ARQ-151 (topical roflumilast cream) in chronic plaque psoriasis and atopic dermatitis at the European Academy of Dermatology and Venereology (EADV) Virtual Congress (EADV Virtual), the Society of Dermatology Physician Assistants (SPDA) Digital 2020 conference, and the virtual 2020 Fall Clinical Dermatology Conference.

“Results from our ongoing clinical development program highlight the clinical benefit of roflumilast cream across multiple outcome measures associated with the treatment of atopic dermatitis and plaque psoriasis,” said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer. “We are pleased to share these significant new data with the medical community at each of this week’s major conferences.”

At the EADV Virtual Congress, October 29-31, 2020, Arcutis will present positive results from a Phase 2 proof-of-concept study on the short-term safety and efficacy of roflumilast cream in patients with mild-to-moderate atopic dermatitis. In addition, the company will highlight data from a Phase 2b study on the impact of roflumilast cream on itch, a highly prevalent and frequently bothersome symptom of chronic plaque psoriasis, and symptom burden. Details of Arcutis’ EADV Virtual Congress presentations include:

• Oral Presentation (FC03.05): Roflumilast Cream (ARQ-151) Improved Itch Severity and Itch-related Sleep Loss in Adults With Chronic Plaque Psoriasis in a Phase 2b Study
  Date: October 29, 2020
  
• Poster Presentation (P1450): Roflumilast Cream (ARQ-151) 0.15% and 0.3% Improved Symptom Burden in Adults With Chronic Plaque Psoriasis in a Phase 2b Study
  Date: October 29, 2020
  
• Oral Presentation (FC08.07): The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Atopic Dermatitis: Phase 2 Proof-of-Concept Study
  Date: October 31, 2020
  

EADV Virtual poster sessions will be available for on-demand viewing starting on October 29, 2020 and oral presentations (free communication) will be available starting on the day of the presentation.

2020 Fall Clinical Dermatology Conference and Society of Dermatology Physician Assistants (SDPA) DIGITAL 2020

Data presentations for roflumilast cream highlighted at the EADV Virtual Congress have also been accepted as poster sessions that will be available for on-demand viewing at the 2020 Fall Clinical Dermatology Conference and SPDA DIGITAL 2020, both of which will held virtually from October 29 – November 1, 2020.

The virtual presentations will be available for on-demand viewing using the links below and under Scientific Publications on the Arcutis website:

• Roflumilast Cream (ARQ-151) Improved Itch Severity and Itch-related Sleep Loss in Adults With Chronic Plaque Psoriasis in a Phase 2b Study: EADV Virtual Congress; 2020 Fall Clinical; SPDA DIGITAL 2020
• Roflumilast Cream (ARQ-151) 0.15% and 0.3% Improved Symptom Burden in Adults With Chronic Plaque Psoriasis in a Phase 2b Study: EADV Virtual Congress; 2020 Fall Clinical; SPDA DIGITAL 2020
• The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Atopic Dermatitis: Phase 2 Proof-of-Concept Study: EADV Virtual Congress; 2020 Fall Clinical; SPDA DIGITAL 2020
  

About Atopic Dermatitis

Atopic dermatitis (AD) is the most common type of eczema, occurring in approximately six percent 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 are paramount.

About Psoriasis

Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

About Arcutis - Bioscience, applied to the skin.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis’ robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The company’s lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow the company on LinkedIn and Twitter.

Forward Looking Statements

This press release contains "forward-looking" statements, including, among others, statements regarding ARQ-151’s potential as a “Best-in-Class” PDE4 inhibitor, ARQ-151’s potential as a treatment for atopic dermatitis and ARQ-151’s potential as a treatment for plaque psoriasis. These statements involve 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 and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the "Risk Factors" section of our Form 10-Q filed with U.S. Securities and Exchange Commission (SEC) on August 11, 2020, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Investors and Media:
Heather Rowe Armstrong
Vice President, Investor Relations & Corporate Communications
harmstrong@arcutis.com
805-418-5006, Ext. 740