Dermatitis, Seborrheic

Findings show that seborrheic dermatitis is a unique inflammatory skin disease with its own molecular signatureSuggests skin barrier disruption in seborrheic dermatitis is distinct with its own disease-specific pattern SAN DIEGO, Calif., March 09, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, highlights new research that, for the first time, reveals the gene expression profile of seborrheic dermatitis. The Arcutis sponsored research from The Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai was presented in a scientific session at the American Academy of Dermatology (AAD) annual meeting (San Diego, CA, March 8 – 12) and answers key questions on the immune response and associated skin barrier disruption of seborrheic dermatitis. “Our research group has had a longstanding interest in defining the immunological pathways that underlie many inflammatory skin diseases, such as atopic dermatitis and psoriasis, shaping our understanding of these diseases and leading to new treatments,” said Emma Guttman-Yassky, MD, PhD, the Waldman Professor of Dermatology and Immunology and Health System Chair of The Department of Dermatology, and Director of the Laboratory for Inflammatory Skin Diseases at the Icahn School of Medicine at Mount Sinai. “We are excited to have successfully employed noninvasive tape-stripping techniques developed from studying these diseases to study an understudied and undertreated inflammatory skin disease, seborrheic dermatitis. These findings will help establish the groundwork for greater understanding of this very common condition.” “The pathophysiology of seborrheic dermatitis has been poorly understood. We sought to understand the gene expression patterns in seborrheic dermatitis in order to determine if this profile is distinct from or similar to other immune-mediated skin conditions,” said Benjamin Ungar, MD, director of the Alopecia Center of Excellence and director of the Rosacea & Seborrheic Dermatitis Clinic at Mount Sinai Health System. “Our data reveal that seborrheic dermatitis has a distinct immunological molecular profile. In addition, the skin barrier disruption observed in seborrheic dermatitis has unique molecular underpinnings, primarily in the tight junction of the epithelial skin cells and lipid metabolism pathways. These findings are the first to characterize the molecular profile of seborrheic dermatitis, and they will play an important role in advancing our understanding of this common and under-treated condition.” Dr. Ungar is also an assistant professor of Dermatology at the Icahn School of Medicine at Mount Sinai. The data reported at AAD are from an observational study in which tape-strips were collected from facial lesions from 27 untreated patients with seborrheic dermatitis (Investigator’s Global Assessment score mild [IGA 2, n=400], moderate [IGA 3, n=19], severe [IGA 4, n=4]) and the facial skin of 18 healthy controls and analyzed with RNA sequencing (RNA-seq). Tape-strips are a non-invasive alternative to biopsy for transcriptome analysis and expression profiling. These data demonstrate that seborrheic dermatitis is an immune disease with a uniquely polarized profile distinct from atopic dermatitis and plaque psoriasis. In addition, skin barrier disruption is suggested by a downregulation of tight junction and lipid metabolism genes. Specific findings include: 1,374 differentially expressed genes (DEGs) were identified between seborrheic dermatitis and healthy controls (674 with increased expression, 700 with decreased expression).Strong and significant upregulation of Th17-related (i.e. IL23A, PI3, LL37) and Th22-related (i.e. IL22, S100A8, S100A12) pathways were detected in seborrheic dermatitis compared with controls.Seborrheic dermatitis also showed significant Th1 activation (OASL, STAT1, CXCL9) compared with controls.There was significant downregulation of skin barrier markers (CLDN1/8, FA2H, ELOVL3) in seborrheic dermatitis compared with controls.IGA positively correlated with immune markers, including Th1/IFNG, Th17/IL17A, and Th22/IL22 [r>0.3; P<0.1 for all] and negatively correlated with skin barrier markers (SMPD4, MGLL, PLA2G15 [r≤-0.38; P<0.05]). “Despite the high prevalence of seborrheic dermatitis, there has been little dedicated clinical or basic research into the underlying cause of this chronic, inflammatory skin disease for decades. Through this collaborative research effort, we have begun to shed some light on the pathways involved in the immune response and demonstrate that seborrheic dermatitis is clearly distinct from psoriasis or atopic dermatitis, which may help explain the clinical expression of the disease, and ultimately provide important insights into its management,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis. “We are committed to advancing the scientific understanding of this disease through additional research and collaboration with the larger dermatology research and clinical community.” Mount Sinai has received grants from Arcutis for research conducted by Dr. Ungar and Dr. Guttman. In addition, Dr. Ungar and Dr. Guttman have served as paid consultants for Arcutis. About Seborrheic DermatitisSeborrheic dermatitis affects up to 10 million people in the United States, and is a common, chronic, and recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often in areas of the body with oil-producing (sebaceous) glands, including the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back. About ArcutisArcutis 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, and X. Forward-Looking StatementsArcutis 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 genetic profile and cause of seborrheic dermatitis. 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:MediaAmanda Sheldon, Head of Corporate Communicationsasheldon@arcutis.com InvestorsLatha Vairavan, Vice President, Finance and Investor Relationslvairavan@arcutis.comDerek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com

Target RWE Shares Latest Updates on Enrolled Alopecia Areata, Atopic Dermatitis, Hidradenitis Suppurativa, and Chronic Spontaneous Urticaria Patients DURHAM, N.C., March 8, 2024 /PRNewswire/ -- New patient-reported outcomes data presented at AAD 2024 from Target RWE's TARGET-DERM AA registry confirms the high unmet need and significant disease burden in patients with moderate to severe alopecia areata (AA). TARGET-DERM is the largest and most comprehensive longitudinal RWE study observing patients with immune-mediated inflammatory skin conditions in the United States. Continue Reading AA is an autoimmune disease that affects about 1 in 50 people. Patients with AA have a high unmet medical need due to comorbid conditions and high impact on quality of life. The most common comorbid conditions associated with AA include vitiligo, atopic dermatitis (eczema), Hashimoto's thyroiditis, psoriasis, and systemic lupus erythematosus. Mental health comorbidities including anxiety and depression are also common due to the psychological impact of hair loss and the social stigma associated with the condition. To date, TARGET-DERM has enrolled 6,000+ patients with immune-mediated inflammatory skin conditions in the U.S. Post this TARGET-DERM AA is distinctively positioned to address real-world access to care, disease progression, diagnosis, and treatment in patients with moderate to severe AA. In this large, diverse real-world cohort of AA patients, worsening clinician-reported outcomes and patient-reported outcomes of severity and quality of life were associated with increasing severity of alopecia tool (SALT) scores. Data were analyzed from participant enrollment visits between December 2021 and July 2023 which included medical record data and baseline prospective clinician-reported and patient-reported outcomes. A significant difference in quality of life was observed with the distribution of scores in each SALT category (mild, moderate, severe). Similarly, significant differences were found in the distribution of eyebrow and alopecia totalis and alopecia universalis scores across SALT categories. Increasing scores of PGIS-AA scale (scale of symptom severity) and eyelash outcomes were associated with increasing SALT severity. "Our TARGET-DERM communities have expanded markedly over the past several years. We have critical mass and a rich data source in AA. This is allowing us to take a deep dive into diagnosis and treatment patterns that influence health outcomes across large populations," said Maria Hordinsky, MD, Professor and Chair of the Department of Dermatology at the University of Minnesota, Minneapolis, MN. Dr. Hordinsky is a member of the TARGET-DERM AA Steering Committee. "There are many features of immune-mediated inflammatory skin disease that are outside of the historically measured severity scores observed by clinicians. For example, alongside visible skin lesions in atopic dermatitis, other factors such as the patient's experience of itch, difficulty sleeping, and other quality-of-life measures are very important parts of the disease," said Benjamin Ungar, MD, Director of the Alopecia Center of Excellence, Rosacea & Seborrheic Dermatitis Clinic, Assistant Professor in the Department of Dermatology, Icahn School of Medicine at Mount Sinai. Dr. Ungar is also a member of the TARGET-DERM AA Steering Committee and receives compensation as an advisor. "What's important about our data presented at AAD and TARGET-DERM AA is that we are gaining insights on the impact of the disease. There are meaningful ways that this data can help inform improved assessment and treatment by healthcare professionals, ultimately changing the trajectory of disease progression and quality of life for patients," said Michael W. Fried, MD, FAASLD, Co-Founder and Chief Medical Officer, Target RWE. TARGET-DERM is an ongoing longitudinal, observational registry that characterizes the natural history of patients with immune-mediated inflammatory skin conditions in the real world through a consortium of academic and community sites in the U.S. and Canada. To date, Target RWE has enrolled more than 6,000+ patients in the registry with atopic dermatitis, alopecia areata, hidradenitis suppurativa, and chronic spontaneous urticaria. About Target RWE Target RWE is a distinctly collaborative enterprise that unifies real-world data sets and advanced RWE analytics in an integrated community, shifting the paradigm in healthcare for how decisions are made to improve lives. Target RWE's industry-leading biorepository of consented biospecimen samples has surpassed more than 150,000 which can be instrumental in helping predict disease progression in prominent therapeutic areas including liver disease, immune-mediated skin conditions, and gastroenterology. The collection contains a wealth of population-level genetic data that can be paired with clinical outcomes and disease progression data from Target RWE's extensive longitudinal patient registries. These samples are collected leveraging an IRB-approved protocol and linked to de-identified clinically validated data derived from patient medical records and patient research outcomes measures. Target RWE sources unique, connected data sets across multiple therapeutic areas representing granular data from diverse patients in academic and community settings. Our rigorous, interactive, and advanced RWE analytics extract deep insights from RWD to answer important questions in healthcare. Target RWE brings together the brightest minds in healthcare through an unmatched community of key opinion leaders, patients, and healthcare stakeholders in a collaborative and dynamic model. Follow us on X (@TargetRWE) and LinkedIn to keep up with the latest news! Contact: Kayla Slake Senior Manager, Marketing [email protected] 984.234.0268 ext 205 SOURCE Target RWE

Late breaking sessions to highlight new data from the INTEGUMENT-PED trial evaluating roflumilast cream 0.05% in children ages 2-5 with atopic dermatitisNew patient-reported outcomes including pruritus data from two pooled Phase 3 trials (DERMIS-1 and DERMIS-2) of ZORYVE® (roflumilast) cream 0.3% in plaque psoriasisNew efficacy and patient-reported outcome data of ZORYVE (roflumilast) topical foam, 0.3%, in seborrheic dermatitis and investigational roflumilast foam in scalp and body psoriasis WESTLAKE VILLAGE, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced five presentations at the 2024 American Academy of Dermatology (AAD) annual meeting, which will take place in San Diego, CA from March 8 - 12, 2024. Among these presentations will be late-breaking clinical data on roflumilast cream 0.05% in patients 2 to 5 years of age with mild to moderate atopic dermatitis from the pivotal INTEGUMENT-PED Phase 3 randomized controlled trial. “Our significant presence at this year’s AAD is a testament to our commitment to bringing meaningful innovation in immuno-dermatology, and building on the body of evidence supporting our topical roflumilast development program. In particular, we are excited to be participating in the late breaking data presentations with new results from INTEGUMENT-PED, as part of our atopic dermatitis clinical program,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis. “We appreciate the opportunity to participate in the AAD and other medical meetings to engage with our peers and progress the medical dermatology field.” Presentation details follow: Late Breaking Data PresentationEfficacy 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 TrialPresenting Author: Dr. Lawrence EichenfieldTime: March 10, 2024, 2:30 PM PTRoom: 20BCD Oral Poster PresentationRoflumilast Cream 0.3% in Patients With Psoriasis: Improvement in Patient Reported Outcomes and Pruritus From Two Pooled Phase 3 Trials (DERMIS-1/DERMIS-2)Presenting Author: Dr. Mark LebwohlTime: March 9, 2024, 3:25 PM PTRoom: Upper Level, Sails Pavilion, Poster Center 2 The following posters will be electronically available for the entirety of the conference and online beginning Friday, March 8, 2024: 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 53863 Roflumilast Foam 0.3% Once Daily in Patients With Seborrheic Dermatitis: Improvement in Patient Reported Outcomes and Pruritus From a Phase 3 Trial (STRATUM)Bhatia, N et al.ePoster 53894 Patient-Reported Outcomes With Roflumilast Foam 0.3% in Patients With Scalp and Body Psoriasis in the Phase 3 ARRECTOR TrialGooderham, M et al.ePoster 53817 Roflumilast Cream 0.3% in Patients With Psoriasis: Improvement in Patient Reported Outcomes and Pruritus From Two Pooled Phase 3 Trials (DERMIS-1/DERMIS-2)Lebwohl, M et al.ePoster 53025 About ArcutisArcutis 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, 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 Derek Cole Investor Relations Advisory Solutions derek.cole@iradvisory.com