• Once-daily, steroid-free roflumilast foam 0.3% demonstrated significant improvements in both scalp and body psoriasis across all efficacy endpoints compared to vehicle
• New data highlights a significant reduction in scalp itch observed as early as 24 hours following the first application of roflumilast foam, as measured by change in baseline in Scalp Itch-Numeric Rating Score (SI-NRS)
• Patients reported a significant improvement in scaling, itch, and pain at Week 8, with significantly more individuals treated with roflumilast foam achieving a Psoriasis Symptom Diary (PSD) score of 0, or clear, compared to vehicle

WESTLAKE VILLAGE, Calif., Oct. 13, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new data from its pivotal ARRECTOR Phase 3 trial of roflumilast foam 0.3% for the treatment of adults and adolescents with scalp and body psoriasis. Roflumilast foam 0.3% is an investigational once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor being developed to treat inflammatory dermatoses, particularly in hair-bearing areas of the body such as the scalp, face, and trunk. The results, including new patient-reported outcome data, were presented at the EADV Congress held October 11-14, 2023, in Berlin.

New data presented in Berlin demonstrate improvements in both scalp and body itch. Two thirds (65.3%) of roflumilast-treated patients achieved a clinically significant reduction in itch compared to 30.3% of vehicle-treated patients at Week 8 (P<0.0001) as measured by a four-point (4-pt) change from baseline in SI-NRS. Importantly, a rapid and significant improvement in scalp itch was observed 24 hours following first application as measured by SI-NRS (P=0.0164).

“Scalp psoriasis, which presents in about 40 percent of people with psoriasis, is often associated with itch and is the most burdensome symptom of the disease,” said Melinda Gooderham, MSc, MD, FRCPC, medical director, SKiN Centre for Dermatology, and investigator with Probity Medical Research. “These data show that roflumilast foam significantly improved scalp psoriasis across multiple efficacy endpoints, including a notably rapid and significant reduction in itch as early as the first treatment. Coupled with a favorable safety and tolerability profile, these efficacy data demonstrate the potential for roflumilast foam as a treatment option designed to overcome the limitations of traditional creams and ointments for hair-bearing areas of the body.”

In addition, improvement in body itch as measured by the Worst Itch Numeric Rating Scale (WI-NRS) was also observed at Week 8, with 63.1% of those treated with roflumilast foam achieving a WI-NRS 4-pt response compared to 30.1% of those treated with vehicle (P<0.0001).

Patient-reported outcomes, as reported by the PSD, also improved. Patients in the study were given a 16-item PSD questionnaire to assess efficacy by asking participants to rate the severity and burden of their psoriasis-related symptoms in the past 24 hours.

• At Week 8, a statistically significantly greater percentage of patients achieved an aggregate PSD score of 0 (i.e., no symptoms) for scaling, itch, and pain, with 19.6% of patients treated with roflumilast foam reporting no scaling, itch, or pain compared to 7.1% of those treated with vehicle (P=0.0012).
• Regarding severity of scaling, 41.5% of roflumilast-treated patients achieved a PSD score of 0 vs. 13.6% of vehicle-treated patients (P<0.0001). For severity of itch, 31.7% of roflumilast-treated patients achieved a PSD score of 0 vs. 10.0% of vehicle-treated patients (P<0.0001).
• Similarly, regarding severity of pain, 64.9% of individuals treated with roflumilast foam achieved a PSD score of 0 compared to 40.3% of individuals treated with vehicle (P<0.0001).

A total of 432 adults and adolescents ages 12 and over were enrolled in the study. In the study, the extent of scalp involvement of study participants was approximately one-third of the scalp surface area (34.4% for those treated with roflumilast foam, 36.0% in those treated with a vehicle foam). Previous use of a topical steroid was reported by 81.9% of study participants, and 58.6% of participants in the study reported inadequate response, intolerance, or contraindication to topical steroids.

“These data from the ARRECTOR trial show once-daily topical roflumilast foam achieved early and significant improvements in psoriasis signs and symptoms on both the scalp and body, including in patients who have already failed standard-of-care topical steroids, suggesting investigational roflumilast foam may be an important topical treatment option,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis. “We are pleased to share these results with the medical dermatology community at EADV as we further explore the potential of roflumilast foam in patients with psoriasis in hair-bearing areas of the body, which are traditionally challenging to treat.”

As previously reported, ARRECTOR met both co-primary endpoints of Scalp-Investigator Global Assessment (S-IGA) Success and Body-Investigator Global Assessment (B-IGA) Success (S-IGA and B-IGA of Clear [0] or Almost Clear [1] plus ≥2-grade improvement from baseline) at Week 8 and all secondary endpoints. Specifically, 66.4% of individuals treated with roflumilast foam achieved S-IGA Success compared to 27.8% of individuals treated with a vehicle foam at Week 8 (P<0.0001), and 45.5% of individuals treated with roflumilast foam achieved B-IGA Success compared to 20.1% of individuals treated with a matching vehicle foam at Week 8 (P<0.0001).

Roflumilast foam 0.3% was well tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and generally similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. Overall, the most common adverse events in the study population (≥2%) included headache (4.6%), diarrhea (3.2%), COVID-19 (2.8%), and nausea (2.1%). Rates of discontinuation due to adverse events were low and similar among roflumilast-treated (1.8%) and vehicle-treated (1.3%) patients.

About ARRECTOR
The “A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis” (ARRECTOR) study was a parallel group, double blind, vehicle-controlled pivotal Phase 3 study of the safety and efficacy of roflumilast foam 0.3% or a matching vehicle administered once-daily in subjects with scalp and body psoriasis ages 12 and older. A total of 432 subjects were enrolled in the study. The co-primary endpoints of the study were the proportion of subjects achieving S-IGA Success and the proportion of subjects achieving B-IGA Success, with IGA Success defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement from baseline after eight weeks.

About Scalp and Body Psoriasis
Scalp psoriasis is a manifestation of plaque psoriasis characterized by raised, red areas of skin (“plaques”) covered with a silver or white scale that occurs 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. Approximately 40 percent of the estimated 9 million Americans with plaque psoriasis have involvement of the scalp. Scalp psoriasis plaques are identical to psoriatic plaques on other areas of the body; however, topical treatment of scalp plaques is complicated by the difficulty of delivering drugs onto the affected skin in hair bearing areas where traditional cream and ointment formulations can be difficult to apply. As with psoriatic plaques on other parts of the body, psoriasis on the scalp is often itchy and is sometimes painful. Scalp psoriasis can also be associated with hair loss, likely due to damage to the hair from excessive scratching, rubbing, or combing of the affected area. Often, patients require two or more medications to manage their psoriasis when they have scalp involvement.

About Topical Roflumilast
Arcutis is developing topical cream and foam formulations of roflumilast, a highly potent and selective PDE4 inhibitor being investigated as a once-daily, nonsteroidal, topical treatment for multiple dermatologic conditions. 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. Roflumilast cream 0.3% (ZORYVE^®) is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients down to the age of 6. Roflumilast cream was evaluated at lower doses for atopic dermatitis: 0.15% for adults and children 6 years of age and older, and 0.05% for children aged 2 to 5 years. Roflumilast foam is a once-daily topical foam formulation of roflumilast which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.

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%).

Please see full Prescribing Information.

ZORYVE is for topical use only and not for ophthalmic, oral, or intervaginal use.

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 www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and X.

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 of roflumilast foam for the treatment of scalp and body psoriasis, the potential to use roflumilast foam over a long period of time, or chronically, the potential to use roflumilast foam anywhere on the body, and the potential for roflumilast cream to advance the standard of care in scalp and body 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 the 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.

Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com