Crisaborole

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 TreatmentsSimpson, 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. INDICATIONSZORYVE 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 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 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 StatementsThis 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:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsLatha Vairavan, Vice President, Finance and Corporate Controllerir@arcutis.com

QUEBEC CITY--( BUSINESS WIRE )--Devonian Health Group Inc. (“ Devonian ” or the “ Corporation ”) ( TSXV: GSD; OTCQB: DVHGF ), a clinical stage corporation focused on developing unique solutions to inflammatory diseases, today announced the results of its in vitro comparative study, which demonstrate the anti-inflammatory effect of Thykamine™, with superior potency on the inflammatory biomarkers as compared to currently marketed anti-inflammatory agents, which included various corticosteroids and a phosphodiesterase inhibitor. The assays were conducted at Department of Microbiology, Infectious Diseases, and Immunology in the Faculty of Medicine at Université Laval (Quebec City) under the leadership of Pr Louis Flamand, PhD, MBA (1) in collaboration with Dr John Sampalis, PhD, Epidemiologist, Medicine Faculty, McGill University and Dr Charles Lynde, MD from Lynde Dermatology and Associate Professor in the Department of Medicine at the University of Toronto. The primary objective of the study was to compare the anti-inflammatory potency of Thykamine™ to other anti-inflammatory agents in the market, specifically betamethasone valerate, clobetasol, crisaborole, 21-acetate hydrocortisone, pimecrolimus and prednisone. The experiment involved treating lipopolysaccharide (LPS) stimulated U937 monocytic cells with each agent. Anti-inflammatory potency was assessed by the percent inhibition of the activity of four cytokines induced by each agent. The four cytokines tested were MCP-1, MIP-1α, MIP-1β and RANTES that have been implicated in several autoimmune diseases. Percent inhibition was calculated as the reduction in lipopolysaccharide (LPS) induced cytokine activity after addition of the agent. Given that the aim of anti-inflammatory drugs is to dampen cytokine induced inflammation, these results can be used as inference to overall anti-inflammatory efficacy. All agents were tested at four increasing concentrations except for pimecrolimus that was tested at three concentrations. All culture conditions were run in hexaplicate (n=6). Cell-free supernatants were collected and immediately assayed for cytokine concentration using Pro-Carta 6 plex (Life Technologies). U937 secreted amounts of IL-6 or IL-10 that were below the detection limits of the assay and were not included in the analyses. When compared to the other agents, Thykamine™ showed clinically important and statistically significant higher inhibition potency for MCP-1 (by 28% to 136%; P< 0.009), MIP-Alpha (by 30% to 108%; P < 0.001), MIP-1 Beta (by 39% to 111%; P < 0.001). For RANTES higher inhibition was observed for all agents (by 47% to 258%) except for Crisaborole and Prednisone. In this assay, pimecrolimus did not inhibit any of the cytokine tested. “ These results support the wide spectrum anti-inflammatory properties of Thykamine™ with potency that is superior to currently marketed anti-inflammatory agents. This study indicates a multi mode of action of Thykamine™ affecting several cytokines and other biomarkers, supporting the clinical efficacy demonstrated in phase 2 studies in ulcerative colitis and atopic dermatitis in adults,” said Dr Louis Flamand, lead study investigator. “ The high potency and previously established clinical efficacy of Thykamine™ , combined with its placebo-like safety, should compel practitioners to consider its use as a first line treatment, especially with the potential safety concerns of the present standard of care,” said Dr Lynde, who was consulted on the current study and was the lead investigator in Devonian’s phase 2 study in adults with mild-to-moderate atopic dermatitis. The study’s co-investigator Dr. John Sampalis, Clinical Epidemiologist, and Professor of Medicine at McGill with extensive experience in the evaluation of treatments for autoimmune disorders commented: “ The results of this in vitro study are extremely encouraging. The favorable safety profile of Thykamine™ as demonstrated in human clinical studies and its high anti-inflammatory potency proven in this study, would position Thykamine™ as a possible first line treatment of choice for several autoimmune conditions in the early stages of the disease. This can result in steroid sparing effect and reduced need for aggressive treatments with biologics and other immune modulators, that are associated with serious side effects and long term negative consequences.” Investigators of this study are planning to submit the results in a peer-reviewed journal. (1) Pr. Louis Flamand is a director on the board of directors of the Corporation About Thykamine™ Thykamine™, the first pharmaceutical product issued from Devonian’s SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large phase II study in adult patients with mild-to-moderate Atopic Dermatitis. Both Thykamine™ and SUPREX™ platform are protected by several patents in North America, Europe and Asia. About Devonian Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune inflammatory conditions with novel therapeutic approaches to targeting unmet medical needs. Devonian’s core strategy is to develop prescription drugs for the treatment of inflammatory autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a U.S. Food and Drug Administration set of regulatory guidelines favoring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare Inc., focused on selling prescription pharmaceutical products in Canada, under license from brand name pharmaceutical companies. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability ‘from the seed to the pill’. Devonian is traded publicly on the TSX Venture Exchange (the “Exchange”) (TSXV: GSD) and on OTCQB exchange (OTCQB: DVHGF). For more information, visit www.groupedevonian.com Cautionary Note Regarding Forward-Looking Statements All statements, other than statements of historical fact, contained in this press release including but, not limited to those relating to the economical impact of clinical study, the efficiency of the high anti-inflammatory potency proven and the position of the Thykamine™ as a possible first line treatment of choice for several autoimmune conditions in the early stages of the disease and the reduced need for aggressive treatments with biologics and other immune modulators, that are associated with serious side effects and long term negative consequences, and, generally, the above “About Devonian” and “About Altius” paragraphs, which essentially describes the Corporation’s outlook, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Corporation disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law. Neither the Exchange nor its Regulation Services Provider (as that term is defined in policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release.