Arcutis Completes Enrollment in DERMIS-1 and DERMIS-2 Pivotal Phase 3 Clinical Trials Evaluating ARQ-151 (Topical Roflumilast Cream) as a Potential Treatment for Plaque Psoriasis

Rhea-AI Summary

Arcutis Biotherapeutics (Nasdaq: ARQT) has completed enrollment in two pivotal Phase 3 trials (DERMIS-1 and DERMIS-2) for its topical roflumilast cream, a potential treatment for plaque psoriasis affecting about 8.6 million patients in the U.S. Topline results are expected in Q1 2021, with a New Drug Application (NDA) submission planned by year-end. Previous Phase 2 studies indicated significant improvements and a favorable safety profile for roflumilast. The cream's unique formulation aims to provide effective treatment without the trade-offs seen in existing therapies.

Positive

• Completion of enrollment in pivotal Phase 3 trials DERMIS-1 and DERMIS-2.
• Topline data from Phase 3 trials anticipated in Q1 2021.
• Positive results from prior Phase 2 studies showing significant symptomatic improvements.
• Roflumilast cream may eliminate the need for trade-offs between efficacy and safety.

Negative

• None.

• Roflumilast cream potential “Best in Class” topical PDE4 inhibitor
  
• Plaque psoriasis affects approximately 8.6 million patients in the U.S.
• Phase 3 trials topline data now anticipated in the first quarter of 2021 and New Drug Application (NDA) submission anticipated by the end of 2021

WESTLAKE VILLAGE, Calif., Sept. 16, 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 the completion of enrollment in DERMIS-1 and DERMIS-2, the Company’s pivotal Phase 3 clinical trials evaluating ARQ-151 (topical roflumilast cream) as a potential topical treatment for plaque psoriasis.

“Patients with plaque psoriasis, a common immune-mediated skin disease, are desperate for new topical options that, unlike existing treatments, don’t require them to make trade-offs between efficacy, safety, and tolerability,” said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer. “We are delighted to complete enrollment in DERMIS-1 and DERMIS-2, our pivotal phase 3 clinical trials evaluating roflumilast cream as a potential once daily topical treatment for plaque psoriasis. If approved, we believe roflumilast cream has the potential to eliminate the need for dermatologists and patients to compromise between efficacy and safety. In two separate prior Phase 2 studies, roflumilast cream demonstrated statistically significant symptomatic improvements and a safety and tolerability profile that supports chronic use and the ability to use in all body areas. We are updating our guidance and now plan to announce topline data from these pivotal Phase 3 trials in the first quarter of 2021 and, if positive, anticipate submission of our NDA to the FDA by the end of 2021.”

Arcutis recently announced positive preliminary results from the first cohort in its ongoing Phase 2 long-term safety study in psoriasis, supporting its belief that roflumilast cream can be used chronically. In addition, The New England Journal of Medicine published results from the double-blind, randomized Phase 2b study of roflumilast cream in plaque psoriasis.

The “Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS” One and Two (or DERMIS-1 and DERMIS-2) are identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or vehicle cream are applied once daily for 8 weeks to subjects age 2 years and above with mild, moderate or severe chronic plaque psoriasis involving between 2% and 20% body surface area. DERMIS-1 enrolled 439 subjects, and DERMIS-2 enrolled 442 subjects. The primary endpoint of the studies is Investigator Global Assessment (IGA) Success, defined as an IGA score of clear or almost clear and at least a 2-grade improvement from baseline at week 8 on the IGA score. Multiple secondary endpoints will also be evaluated, including Intertriginous IGA (I-IGA) Success, and improvements in Psoriasis Area Severity Index (PASI), itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). The Company anticipates topline data from the Phase 3 studies in the first quarter of 2021 and, if positive, anticipates submission of its NDA to the FDA by the end of 2021.

About Topical Roflumilast Cream

Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). 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. 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. 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.

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 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 roflumilast cream’s potential as a psoriasis treatment; and expectations with regard to the timing of clinical data anticipated in the first quarter of 2021 and NDA submission by the end of 2021. 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 May 12, 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.

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

FAQ

What are the latest developments for Arcutis Biotherapeutics' stock symbol ARQT?

Arcutis Biotherapeutics has completed enrollment in two pivotal Phase 3 trials for roflumilast cream, with topline results expected in Q1 2021 and a potential NDA submission by the end of 2021.

What is the significance of the DERMIS-1 and DERMIS-2 trials for ARQT?

These trials are crucial for evaluating the safety and efficacy of roflumilast cream as a treatment for plaque psoriasis, impacting Arcutis' market position and stock performance.

When will Arcutis announce results from the Phase 3 trials?

Topline results from the Phase 3 trials are anticipated in the first quarter of 2021.

What is roflumilast cream's potential in the treatment of plaque psoriasis?

Roflumilast cream is viewed as a potential 'best in class' topical PDE4 inhibitor, aiming to offer effective treatment without compromising safety and tolerability.

How many patients in the U.S. are affected by plaque psoriasis?

Approximately 8.6 million patients in the U.S. are affected by plaque psoriasis.