New Data Shows ZORYVE® (Roflumilast) Cream 0.3% Provided Measurable Improvement of Plaque Psoriasis in Nearly All Individuals in DERMIS Trials

• Individual patient response data highlights 95% of individuals treated with ZORYVE had a measurable improvement in Psoriasis Area and Severity Index (PASI) at Week 8
• Over 85% achieved measurable improvement by Week 2 (the earliest timepoint measured)
• Separately reported new data confirms ZORYVE is well tolerated according to both investigator and patient local tolerability assessments

WESTLAKE VILLAGE, Calif., Oct. 20, 2023 (GLOBE NEWSWIRE) --  (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new individual patient response data showing nearly all individuals (95%) treated with ZORYVE^® (roflumilast) cream 0.3% had a measurable improvement in Psoriasis Area and Severity Index (PASI). Separately reported investigator and patient local tolerability assessment data confirms again that ZORYVE was well tolerated from first application. New analyses from two pivotal Phase 3 studies (DERMIS-1 and DERMIS-2) were presented in two posters at the 43^rd Annual Fall Clinical Dermatology Conference held October 19-22, 2023, in Las Vegas, Nevada. ZORYVE is a once-daily, steroid-free cream for individuals with plaque psoriasis down to 6 years of age that can be used for any duration across all affected areas of the body.

At Week 8, a statistically significant greater percentage of patients achieved a 50% reduction in PASI scores (PASI-50), with 72.1% of patients treated with ZORYVE compared to 25.5% of those treated with vehicle (P<0.0001). At the same 8 week endpoint, a 75% reduction in PASI scores (PASI-75) was achieved in 40.3% of roflumilast-treated patients compared to 6.5% of vehicle-treated patients (P<0.0001). PASI-90 was observed in 19.7% of patients treated with ZORYVE compared to 2.3% of vehicle-treated patients (P<0.0001) and a 100% reduction (PASI-100) was observed in 12.3% of patients treated with ZORYVE compared to 0.8% of vehicle-treated patients (P<0.001).

“Data reported from clinical trials generally show results within the overall study population which is certainly important. However, what it does not show clinicians is the range or pattern of clinical response they can anticipate in the individual patient they are treating. This information is clinically relevant during each office visit with every patient as it directly provides the range of individual patient responses, in this case using PASI scores as the measure of response,” said James Q. Del Rosso, D.O., FAOCD, FAAD, research director and principal investigator, JDR Dermatology Research, and lead author on the individual patient response presentation. “It is impressive that 95% of individual patients treated with ZORYVE cream showed measurable improvement in PASI scores within eight weeks, with an increased magnitude of efficacy noted progressively over the eight weeks duration of treatment. It is also very clinically relevant that 85% showed measurable improvement as early as two weeks. Collectively, this information highlights the efficacy, consistency, and importance of ZORYVE cream as a corticosteroid-free topical treatment for the vast majority of children and adults with plaque psoriasis.”

In other data shared as a poster at the conference, ZORYVE was shown to be very well tolerated in individuals with plaque psoriasis, as measured by both investigator- and patient-rated local tolerability assessed prospectively in the DERMIS-1 and DERMIS-2 clinical trials.

• Nearly no stinging and burning was reported by patients. At first application, Week 4 and Week 8 only 0.4%, 0.0% and 0.2% treated with roflumilast cream reported hot, tingling/stinging sensation vs 0.0%, 0.4% and 0.0% treated with vehicle respectively.
• There was no evidence of irritation per investigator assessment in approximately 99% of subjects at each of the post-baseline time points, Week 4 and Week 8 (98.8% and 98.6% for roflumilast cream vs 97.7% and 98.4% for vehicle, respectively).

The findings included results in those with involvement in sensitive areas such as the face (26.6%), genital (15.6%), and intertriginous areas (20.3%), where skin touches skin.

"For a topical cream to be consistently used by patients, it needs to be safe and effective, but also well tolerated,” said Christopher Bunick, MD, PhD, associate professor of dermatology, Yale University School of Medicine, and lead author on the tolerability presentation. “The patient-reported results reinforce the excellent tolerability profile of ZORYVE and demonstrate that tolerability issues, in particular stinging and burning, are not a class effect associated with PDE4 inhibition. This makes ZORYVE an important non-steroidal topical option for patients.”

ZORYVE safety and tolerability data were comparable with vehicle, with low rates of application site adverse events (AEs), treatment-related AEs, and discontinuations due to AEs. The most common adverse reactions (≥1%) 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%).

“We are pleased to be able to share these individual PASI response data with the wider dermatology community, along with data highlighting the strong alignment between both investigator and patient-reported assessments of tolerability,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis. “As we continue to collect and analyze data highlighting the robust efficacy and tolerability of ZORYVE cream, we gain a greater understanding of the important role that this next generation topical PDE4 inhibitor may play in addressing unmet treatment needs of those with plaque psoriasis.”

Poster Details

Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Individual Patient Response from the Pooled DERMIS-1 and DERMIS-2 Phase 3 Trials

James Del Rosso et al.

Investigator- and Patient-Rated Local Tolerability in Phase 3 Trials of Topical Roflumilast in Patients with Psoriasis, Seborrheic Dermatitis, and Atopic Dermatitis

Christopher G. Bunick et al.

About DERMIS Pivotal Phase 3 Trials

DERMIS-1 and DERMIS-2 (Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS” One and Two) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies to evaluate the safety and efficacy of roflumilast cream 0.3% applied once-daily. A total of 831 individuals aged 2 years and above with mild, moderate, or severe chronic plaque psoriasis involving between 2% and 20% body surface area were enrolled in the studies.

Investigator-rated local tolerability was assessed on an 8-point scale and conducted by the investigator prior to treatment application in the clinic. Patient-rated local tolerability was rated on a 4-point scale and reported by the patient 10-15 minutes following treatment application in clinic.

About Plaque Psoriasis

Psoriasis is a common, non-contagious, immune-mediated skin disease that affects more than 8.6 million people in the United States. The majority of patients develop “plaques,” or raised, red areas of skin covered with a silver or white layer of dead skin cells. The plaques clinical presentation may have more grayish, purplish, or brownish tones in people with skin of color. Psoriatic plaques are often itchy and sometimes painful, and can appear on any area of the body. Plaques in certain anatomical areas present unique treatment challenges, including the face, elbows and knees, scalp, and intertriginous areas (where two skin areas may touch or rub together).

About ZORYVE^®

ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older.

IMPORTANT SAFETY INFORMATION

ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

The most common adverse reactions (≥1%) 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%).

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About Arcutis

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a 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 that harnesses 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, seborrheic dermatitis, and alopecia areata. For more information, visit  or follow Arcutis on , , and .

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 ZORYVE to simplify disease management for care of plaque psoriasis, including in children, the potential of real-world use results of roflumilast cream, as well as the commercial launch of ZORYVE in plaque psoriasis. 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 28, 2023, 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.

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