Arcutis to Present New Roflumilast Cream Phase 3 Data at The European Academy of Dermatology and Venereology (EADV) Spring Symposium

Rhea-AI Summary

Arcutis Biotherapeutics (Nasdaq: ARQT) is set to present data from pivotal Phase 3 studies, DERMIS-1 and DERMIS-2, evaluating the efficacy and safety of roflumilast cream for chronic plaque psoriasis at the EADV Spring Symposium on May 6-7, 2021. The research involved 881 subjects and focused on the drug's potential as a once-daily topical treatment. Chief Medical Officer Patrick Burnett expressed excitement over the opportunity to share findings at this respected dermatology forum, emphasizing the significance of the study led by renowned psoriasis expert, Dr. Mark Lebwohl.

Positive

• Successful completion of DERMIS-1 and DERMIS-2 studies with a total of 881 enrolled subjects.
• Potential for roflumilast cream to become a once-daily topical treatment for chronic plaque psoriasis.
• Accepted presentation at the EADV Spring Symposium, highlighting the importance of the research.

Negative

• None.

Presentation will highlight efficacy and safety data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential topical once-daily treatment for chronic plaque psoriasis

WESTLAKE VILLAGE, Calif., May 03, 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 efficacy and safety data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential once-daily topical treatment for chronic plaque psoriasis at the European Academy of Dermatology and Venereology (EADV) Spring Symposium May 6 - May 7, 2021.

“The EADV symposium is an important and respected venue for exchanging information on the latest research and innovations in the field of dermatology,” said Patrick Burnett,  M.D., Ph.D., FAAD, Chief Medical Officer, Arcutis. “We are thrilled the pivotal phase 3 data for roflumilast cream in the treatment of chronic plaque psoriasis has been accepted in the program as an oral presentation and look forward to sharing the findings with the dermatology community. We are also delighted that Dr. Mark Lebwohl, who participated in the study and is one of the world’s leading authorities on psoriasis, will present the studies’ results.”

The “Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS” One and Two (or DERMIS-1 and DERMIS-2) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or matching vehicle cream were 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 was IGA Success at week 8. Multiple secondary endpoints were also evaluated, including I-IGA Success, and improvements in Psoriasis Area Severity Index (PASI), itch as measured by the WI-NRS and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD).

Details of Arcutis’ EADV Spring Symposium presentation is as follows:

• Free Communications (FC01.04): Roflumilast cream, a once-daily, potent phosphodiesterase-4 inhibitor, in chronic plaque psoriasis patients: Efficacy and safety from DERMIS-1 and DERMIS-2 Phase 3 trials
  Date: May 6, 2021
  Time: 14:30 – 14:40 CEST
  Presenter: Mark Lebwohl, M.D. Professor and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai

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 #EADVSymposium.

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 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 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

FAQ

What are the DERMIS-1 and DERMIS-2 studies for ARQT?

DERMIS-1 and DERMIS-2 are pivotal Phase 3 randomized studies evaluating the efficacy and safety of roflumilast cream for chronic plaque psoriasis.

When will Arcutis present the Phase 3 study results?

The results will be presented at the EADV Spring Symposium on May 6, 2021.

What is roflumilast cream and its purpose in ARQT's studies?

Roflumilast cream is a topical formulation aimed at treating chronic plaque psoriasis as a once-daily application.

How many subjects were involved in the DERMIS studies?

The DERMIS studies enrolled a total of 881 subjects, with 439 in DERMIS-1 and 442 in DERMIS-2.