Arcutis Biotherapeutics (ARQT) Announces New Data Shows ZORYVE Cream 0.3% Provided Measurable Improvement of Plaque Psoriasis in Nearly All Individuals in DERMIS Trials

Arcutis Biotherapeutics, Inc. (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.

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