Reformulated, Topical Dermatology Products

Arcutis Biotherapeutics focuses on developing innovative treatments for immune-mediated skin diseases, particularly through its proprietary platform centered around phosphodiesterase 4 (PDE4) inhibitors. The company has made significant strides with its lead product, ZORYVE (roflumilast), available in both cream and foam formulations. These products are designed to address various dermatological conditions, including plaque psoriasis, atopic dermatitis, seborrheic dermatitis, scalp psoriasis, chronic hand eczema, vitiligo, and alopecia areata. The PDE4 inhibitors work by modulating inflammatory pathways, thereby reducing the symptoms associated with these chronic skin conditions. Arcutis emphasizes the importance of patient-centered innovation, aiming to simplify the management of complex dermatological diseases and improve the quality of life for patients.

In addition to ZORYVE, Arcutis is advancing a robust pipeline of topical therapies, including ARQ-252, ARQ-255, and ARQ-234, which target various dermatological indications. The company has conducted pivotal clinical trials, such as the ARRECTOR study, which demonstrated the efficacy and safety of roflumilast foam in treating scalp and body psoriasis. The results indicated significant improvements in patient outcomes, showcasing Arcutis' commitment to addressing unmet medical needs in dermatology. By leveraging its deep expertise in medical dermatology and a thorough understanding of patient challenges, Arcutis aims to deliver meaningful innovations that enhance treatment options for those suffering from chronic inflammatory skin diseases.

United States

Arcutis (Nasdaq: ARQT) was founded in 2016 to address significant unmet needs in medical dermatology. The company is an early commercial stage biopharmaceutical company focused on developing and commercializing best-in-class products.

Our strategy is to exploit recent innovations in inflammation and immunology to bring the best molecules to bear against validated physiologic targets known to treat dermatological diseases and disorders. 

Our management team has extensive expertise in the development and commercialization of medical dermatology products, having held key leadership roles at a number of leading dermatology companies and, collectively, has successfully developed more than 50 FDA-approved products. We believe that by leveraging our team’s unique experience and demonstrated expertise to identify, develop and commercialize best-in-class molecules against validated targets, we will be able to develop differentiated products in less time, at lower cost, and at substantially lower risk than other approaches.

Arcutis'​ combination of vision, unmet medical need, experienced management and strategic approach has attracted support from leading investors in the life sciences sector.

Skin Diseases

Arcutis Biotherapeutics

Atopic dermatitis

Topical roflumilast cream (ARQ-151) is a small molecule inhibitor of phosphodiesterase type 4 (PDE4), an intracellular enzyme that increases the production of proinflammatory mediators and decreases production of anti-inflammatory mediators, and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and chronic obstructive pulmonary disease (COPD). PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical or systemic treatment of plaque psoriasis and atopic dermatitis. Topical roflumilast cream is a highly potent, selective PDE4 inhibitor in a convenient, once-daily formulation that Arcutis is developing for chronic plaque psoriasis and atopic dermatitis. Roflumilast is 25–300X more potent than the two other FDA-approved PDE4 inhibitors used in dermatology and has a well-established safety profile with more than 1 million patient years of exposure in clinical use.

ZORYVE® (ARQ-151) topical roflumilast cream

Psoriasis

Skin disease/disorder

Topical roflumilast foam (ARQ-154) is a foam formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011.&nbsp; Roflumilast has shown greater potency based on IC50 values (a non-clinical measure of a drug’s potency) than any other disclosed PDE4 inhibitor.&nbsp; 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, eczema, and COPD.&nbsp; PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.
<a href="https://arcutis.com/trial/arq-154/">Source&nbsp;</a>

ZORYVE® (roflumilast) Topical Foam 0.3%

Seborrheic dermatitis

Topical roflumilast foam (ARQ-154) is a foam formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011.&nbsp; Roflumilast has shown greater potency based on IC50 values (a non-clinical measure of a drug’s potency) than any other disclosed PDE4 inhibitor.&nbsp; 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, eczema, and COPD.&nbsp; PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.
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 <li><a href="https://arcutis.com/trial/arq-154/">Source</a></li>
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ZORYVE® (Roflumilast foam 0.3%)

Chronic obstructive pulmonary disease

Pulmonary hypertension

Topical roflumilast cream (ARQ-151) is a small molecule inhibitor of phosphodiesterase type 4 (PDE4), an intracellular enzyme that increases the production of proinflammatory mediators and decreases production of anti-inflammatory mediators, and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and chronic obstructive pulmonary disease (COPD).

Topical roflumilast cream (ARQ-151) is a small molecule inhibitor of phosphodiesterase type 4 (PDE4), an intracellular enzyme that increases the production of proinflammatory mediators and decreases production of anti-inflammatory mediators, and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and chronic obstructive pulmonary disease (COPD). PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical or systemic treatment of plaque psoriasis and atopic dermatitis. Topical roflumilast cream is a highly potent, selective PDE4 inhibitor in a convenient, once-daily formulation that Arcutis is developing for chronic plaque psoriasis and atopic dermatitis. Roflumilast is 25–300X more potent than the two other FDA-approved PDE4 inhibitors used in dermatology and has a well-established safety profile with more than 1 million patient years of exposure in clinical use.

ZORYVE® (ARQ-151) topical roflumilast cream 0.05%

Alopecia areata

ARQ-255 is an&nbsp;alternative topical formulation of&nbsp;ARQ-252 designed to reach deeper into the skin to the postulated site of&nbsp;inflammation in&nbsp;alopecia areata. Arcutis currently has formulation and preclinical efforts underway for ARQ-255, which, if successful, will allow ARQ-255 to enter the clinic as potentially the only topical treatment for alopecia&nbsp;areata.

ARQ-255 topical ivarmacitinib

ARQ-234

Vitiligo

ARQ-252 is a potent &nbsp;and highly selective topical, small molecule inhibitor of Janus kinase &nbsp;type 1 (JAK1). Many inflammatory cytokines and other signaling molecules &nbsp;rely on the JAK pathway, and specifically JAK1, which plays a central &nbsp;role in immune system function. Inhibition of JAK1 has been shown to &nbsp;treat a range of inflammatory diseases, including rheumatoid arthritis, &nbsp;Crohn’s disease, and atopic dermatitis. The Company believes that due to &nbsp;its high selectivity for JAK1 over JAK2, ARQ-252 has the potential to &nbsp;effectively treat inflammatory diseases without causing the &nbsp;hematopoietic adverse effects typically associated with JAK2 inhibition. &nbsp;In 2018, Arcutis exclusively licensed the active pharmaceutical &nbsp;ingredient in ARQ-252 for all topical dermatological uses in the United &nbsp;States, Europe, Japan and Canada from Jiangsu Hengrui Medicine Co., Ltd. &nbsp;of China. In mid-2019, Hengrui completed a Phase 2b study in rheumatoid &nbsp;arthritis that used the same active pharmaceutical ingredient as in &nbsp;ARQ-252 but dosed orally. The results confirmed that this active &nbsp;pharmaceutical ingredient is a highly potent inhibitor of JAK1 based on &nbsp;the drug’s impact on rheumatoid arthritis, and was generally well &nbsp;tolerated at exposures well above those expected with topical &nbsp;administration of ARQ-252 in patients with chronic hand eczema. In 2020, &nbsp;Reistone Biopharma, a subsidiary of Hengrui, announced positive topline &nbsp;results from a Phase 2 clinical trial evaluating the oral version of &nbsp;the active ingredient in ARQ-252 for the treatment of moderate-to-severe &nbsp;atopic dermatitis. Reistone Biopharma is also studying the oral &nbsp;formulation as a potential treatment for alopecia areata, Crohn’s &nbsp;disease, and ulcerative colitis.

ARQ-252 (JAKi)

Eczema

ARQ-252 is a topical JAK1 inhibitor that has promise as a novel treatment for inflammatory dermatologic diseases, including hand eczema and vitiligo. Many inflammatory cytokines and other signaling molecules rely on the JAK pathway, and specifically JAK1, which plays a central role in immune system function.&nbsp; Inhibition of JAK1 has been shown to treat a range of inflammatory diseases, including rheumatoid arthritis, psoriasis, Crohn’s disease, and atopic dermatitis.
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 <li><a href="https://arcutis.com/trial/arq-252/">Source</a></li>
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Arcutis Biotherapeutics

Company Details