Arcutis Biotherapeutics to Present New Roflumilast Data at The American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX)

Apr 19, 2021

Presentations will highlight new data on the safety, efficacy, and tolerability of once-daily, topical roflumilast cream for the treatment of chronic, mild-to-severe plaque psoriasis as well as once-daily, topical roflumilast foam for the treatment of scalp and body psoriasis and seborrheic dermatitis.

WESTLAKE VILLAGE, Calif., April 19, 2021 (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, will present new data from three studies evaluating the safety, efficacy, and tolerability of its once-daily, topical roflumilast cream and foam at the American Academy of Dermatology Virtual Meeting Experience (VMX) April 23 - 25, 2021.

“Patients suffering from plaque psoriasis, scalp psoriasis, and seborrheic dermatitis have significant unmet needs given the lack of efficacious, safe, tolerable topical options for long-term use,” said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer, Arcutis. “We are pleased to share these new data that further reinforce the potential of roflumilast cream and foam in various inflammatory skin diseases. If approved by the FDA, our therapies could change the treatment paradigm for patients and their providers in addressing challenging inflammatory dermatological conditions that can significantly impact quality of life.”

The data include positive results from a Phase 2b study of roflumilast foam for the treatment of scalp and body psoriasis, as well as a Phase 2 study of roflumilast foam in patients with seborrheic dermatitis.

Two additional poster slide presentations will feature sub-analyses from the previously published Phase 2b study of roflumilast cream in the treatment of chronic, mild-to-severe plaque psoriasis: 1) the correlation of itch response to roflumilast cream with disease severity and patient-reported outcomes, and 2) the treatment of steroid-sensitive areas of the body including the face, neck, and intertriginous areas.

Finally, Dr. Kim Papp will present results from a new measurement, PASI-HD, which he developed in conjunction with the Arcutis medical team and which was used in the Phase 2b study of roflumilast cream in plaque psoriasis. In areas where the affected body surface area is low (<10%), PASI-HD better distinguishes disease severity than the traditional Psoriasis Area and Severity Index (PASI), which is a gold standard measure in psoriasis clinical trials.

Details of Arcutis’ AAD Virtual Congress presentations include:

  • Late-breaking Oral Presentation (PSO 204): Once-daily Roflumilast Foam 0.3% for Scalp and Body Psoriasis: A Randomized, Double-blind, Vehicle-controlled Phase 2b Study
    Date: April 24, 2021

  • Poster Presentation Plus Recording (SebDerm 203): Efficacy and Safety of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis in a Randomized, Double-blind, Vehicle-controlled Phase 2 Study 
    Date: April 23, 2021

  • Poster Presentation (PSO 201): Correlation of Itch Response to Roflumilast Cream with Disease Severity and Patient-Reported Outcomes in Patients with Chronic Plaque Psoriasis 
    Date: April 23, 2021

  • Poster Presentation (PSO 201): Roflumilast Cream Significantly Improves Chronic Plaque Psoriasis in Patients with Steroid-Sensitive Area Involvement
    Date: April 23, 2021

  • Poster Presentation (PSO 201): The PASI-HD Improved Precision in Measuring Disease Severity in Subjects with Mild-to-Moderate Plaque Psoriasis Treated with Roflumilast Cream, a Phosphodiesterase-4 Inhibitor
    Date: April 23, 2021

Roflumilast is a highly potent phosphodiesterase-4 (PDE4) inhibitor in development for plaque psoriasis (PsO). Arcutis is investigating roflumilast as a once-daily, nonsteroidal, topical treatment for plaque psoriasis, atopic dermatitis, seborrheic dermatitis, and scalp psoriasis.

For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter. Join the conversation with the hashtag #AADVMX2021.

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.

Scalp psoriasis is a manifestation of plaque psoriasis characterized by plaques in the hair-bearing area of the scalp and sometimes extending to the forehead, back of the neck, or behind or inside the ears. Patients with scalp psoriasis commonly have plaques on other areas of the body as well. Scalp psoriasis is present in nearly half of Americans with psoriasis. As with psoriatic plaques on other parts of the body, scalp psoriasis is often itchy and sometimes painful. It can also be associated with hair loss.

About Seborrheic Dermatitis
Seborrheic dermatitis affects more than 10 million people in the United States, and is a common, chronic, or recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often on the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back.

About Topical Roflumilast Cream and Foam
Roflumilast Cream and Foam are once-daily, topical formulations of a highly potent and selective PDE4 inhibitor (roflumilast). The foam formulation was developed to treat inflammatory dermatoses in hair-bearing areas of the body, such as the scalp, although it is usable in all areas of the body. 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 for dermatology. 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, atopic dermatitis, 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 and the systemic treatment of plaque psoriasis.

About Arcutis
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 https://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 the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, 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.

Investor and Media Contact:
Heather Rowe Armstrong
harmstrong@arcutis.com
805-418-5006 ext. 740

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