Dermavant Reports Positive Topline Results from ADORING 1, the Second Atopic Dermatitis Phase 3 Trial of VTAMA^® (tapinarof) Cream, 1% in Adults and Children as Young as 2 Years Old

– 45.4% of subjects receiving VTAMA achieved the primary endpoint of vIGA-AD^TM response of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8, versus 13.9% on vehicle (P<0.0001) –

– All secondary endpoints were met with statistical significance, including 55.8% of subjects treated with VTAMA who achieved the key secondary endpoint of EASI75 at Week 8 (P<0.0001) –

– Meaningful impact on the exploratory endpoint of pruritus (itch) was demonstrated with 61.1% of subjects, with a baseline PP-NRS score ≥4, achieving a ≥4-point reduction in the PP-NRS at Week 8 (P<0.0001) –

– 91% of subjects from ADORING 1 & 2 elected to enroll into the Phase 3 ADORING 3 open-label, long-term safety study* –

– ADORING 1 met the primary and all key secondary endpoints, consistent with the positive topline results from the Phase 3 ADORING 2 trial reported in March –

– sNDA for VTAMA in atopic dermatitis anticipated to be filed with the FDA in Q1 2024 –

LONG BEACH, Calif., and BASEL, Switzerland, May 16, 2023 – Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced positive results from ADORING 1, the second of two double-blind, randomized, vehicle-controlled Phase 3 studies to evaluate the efficacy and safety of topical VTAMA® (tapinarof) cream, 1% in adults and pediatric subjects down to 2 years old with moderate to severe atopic dermatitis (AD).

In ADORING 1 (N=407), VTAMA met the primary endpoint of the trial and demonstrated highly statistically significant improvement in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD^TM) score of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8 (P<0.0001).

Additionally, VTAMA demonstrated highly statistically significant improvement in the proportion of subjects with ≥75% improvement in the Eczema Area and Severity Index (EASI75) from baseline at Week 8 (P<0.0001), a key secondary endpoint. Subjects 12 years and older receiving VTAMA also experienced a statistically significant improvement in itch with a ≥4-point reduction in the patient reported Peak Pruritus Numeric Rating Scale (PP-NRS) (P=0.0366), another key secondary endpoint.

Table 1: ADORING 1 and ADORING 2 Phase 3 Trials – Primary and Key Secondary Endpoints

¹ Primary Endpoint: Proportion of subjects who achieved a vIGA-AD score of clear (0) or almost clear (1) with
at least a 2-grade improvement from baseline at Week 8.

² Secondary Endpoint: Proportion of subjects with ≥75% improvement in EASI from baseline at Week 8.

³ Secondary Endpoint: Proportion of subjects ≥12 years old with a baseline PP-NRS score ≥4 who achieved ≥4-point reduction in the PP-NRS from baseline at Week 8.

Importantly, when PP-NRS was assessed across the entire VTAMA treated population, 61.1% (P<0.0001) experienced a statistically significant improvement in itch, a highly prevalent symptom among AD sufferers.

Both adult and pediatric AD subjects down to 2 years of age receiving VTAMA in the ADORING trials did so at the same dose and dose regimen as currently approved for adults with plaque psoriasis. Subject to FDA approval in AD, the company believes this could be a key manufacturing, supply chain, and commercial advantage, offering simplicity of treatment to patients, physicians, pharmacists, and payers, regardless of plaque psoriasis or atopic dermatitis diagnosis.

“I am extremely proud to share the positive results from ADORING 1, the second of our two Phase 3 pivotal trials with VTAMA in adults and children as young as 2 years old with moderate to severe atopic dermatitis,” said Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant. “Similar to our ADORING 2 data, VTAMA hit all its primary and secondary endpoints. Subject to FDA approval, we believe that the positive safety and efficacy profile of VTAMA, combined with its treatment simplicity, has the potential to change the approach in the way patients are treated. The success of the ADORING studies marks a significant milestone for the entire Dermavant team, and I would like to extend my heartfelt thanks to the patients and investigators involved in our clinical studies.”

VTAMA is a novel, aryl hydrocarbon receptor agonist, in development as a once-daily, steroid-free, and cosmetically elegant topical cream for the treatment of AD. In the U.S., VTAMA is currently approved for the topical treatment of plaque psoriasis in adults.

Topline Results

In ADORING 1, adult and pediatric subjects down to 2 years of age with moderate to severe AD were randomized at a 2:1 ratio to receive once daily (QD) treatment with VTAMA or vehicle cream.

• At Week 8, 45.4% of subjects treated with VTAMA in ADORING 1 achieved the primary endpoint of a vIGA-AD of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8 (P<0.0001).
• Also at Week 8, 55.8% of subjects treated with VTAMA in ADORING 1 achieved the key secondary endpoint of the proportion of subjects with ≥75% improvement in EASI (P<0.0001).
• 55.8% of subjects ≥12 years old, with a baseline PP-NRS score ≥4, achieved a ≥4-point reduction in the PP-NRS at Week 8 (P=0.0366).
• Importantly, VTAMA data indicated no new safety or tolerability signals in this population including children as young as 2 years old. Adverse events were mostly mild to moderate with a low study discontinuation rate due to adverse events (1.9% VTAMA vs. 3.6% vehicle).
• Adverse events of special interest included contact dermatitis (1.5% VTAMA vs. 2.2% vehicle) and follicular event (10.0% VTAMA vs. 0.7% vehicle).

“Atopic dermatitis affects a significant number of children, and its prevalence continues to grow. Given the increasing need for an effective and well-tolerated, non-steroidal topical treatment option for the pediatric population, the efficacy and safety data from ADORING 1 results are encouraging and, combined with the positive results from the maximal usage pharmacokinetics (MUPK) study, VTAMA appears to have the potential to bring relief to children suffering from this disease,” said Adelaide A. Hebert, MD, professor and chief of pediatric dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann. “The prevalence of itch as an associated symptom makes this condition extremely burdensome not only to the patients suffering from AD, but also their families. In this regard, the itch data from ADORING 1, much like that from ADORING 2, emphasizes VTAMA’s effectiveness when it comes to disease control and VTAMA’s potential to reduce one of atopic dermatitis’ most burdensome symptoms.”

“It is a really exciting time for patients suffering from atopic dermatitis and clinicians who treat them. The positive topline data from ADORING 1 taken together with the positive results previously shown in ADORING 2 indicate that VTAMA has potential as a new non-steroidal topical medication option in atopic dermatitis, that can be used anywhere on the body surface, including sensitive areas, for both adults and children as young as two years old,” said Jonathan Silverberg, MD, PhD, MPH, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences in Washington, DC., and the Director of Clinical Research and Contact Dermatitis.

Dermavant recently released highly favorable results from a pediatric maximal usage pharmacokinetics (MUPK) study of VTAMA in AD. The study demonstrated minimal-to-no systemic exposure despite maximal use in subjects with extensive AD. Subjects were as young as 2 years old with up to 90% body surface area (BSA) affected with a mean BSA of 43%.

On May 24, 2022, Dermavant announced the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of adult plaque psoriasis. The approval made VTAMA the first non-steroidal topical novel chemical entity launched for psoriasis in the U.S. in more than 25 years. VTAMA is approved for mild, moderate, and severe plaque psoriasis – with no label safety warnings or precautions, restrictions on duration of use or body surface area. On July 15, 2022, VTAMA became the #1 prescribed branded topical treatment for plaque psoriasisⁱ in adults and to date has over 145,000 prescriptions written with over 10,000 unique prescribers^†.

IMPORTANT SAFETY INFORMATION

Indication: VTAMA^® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

See full Prescribing Information and Patient Information.

About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis
ADORING is Dermavant’s pivotal Phase 3 atopic dermatitis (AD) clinical program for VTAMA® (tapinarof) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week open-label, long-term extension study.

About Atopic Dermatitis
Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affecting over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 30% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease.

About Dermavant
Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes commercialized, late-stage and earlier-development product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant is also developing VTAMA for the treatment of atopic dermatitis in adults and children and released positive topline results from its ADORING 1 and 2 Phase 3 clinical trials in 1H 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential differentiated treatment option for immunological and inflammatory diseases with multiple potential routes of administration.

For more information, please visit www.dermavant.com and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).

© 2023 Dermavant Sciences, Inc. All Rights Reserved. VTAMA^® is the registered trademark of Dermavant Sciences, GmbH. vIGA-AD™ is the trademark of Eli Lilly and Co.

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Gilmartin:
Laurence Watts
Managing Director
laurence@gilmartinir.com
619-916-7620

dna Communications:
Angela Salerno-Robin
Senior Vice President, Media Relations, Healthcare
ASalerno-Robin@dna-comms.com
212-445-8219

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* Dermavant DOF March 2023.

ⁱ IQVIA National Prescription Audit (NPA) for the 3-month period ending 5/5/2023, reflecting estimates of real-world activity. All rights reserved. 

^† IQVIA NPA for the period 5/20/22 to 5/5/2023, reflecting estimates of real-world activity. All rights reserved.

“Seborrheic dermatitis has long been a disease in need of its own treatment,” said Neal Bhatia MD, Director of Clinical Dermatology at Therapeutics Clinical Research and one of the investigators for Arcutis. “Some of the biggest challenges of current treatments have not only been lack of efficacy and consequences from long-term use, but also the limitations that affect adherence, especially the inability to treat both hair- and non-hair-bearing areas. Roflumilast foam was designed to address these shortcomings, as a once-daily, steroid-free topical drug that can be used chronically anywhere on the body. Dermatologists will be excited to incorporate roflumilast foam, if approved, as a new standard of care for those living with seborrheic dermatitis.”

Roflumilast foam is an investigational once-daily, topical 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.

Seborrheic dermatitis affects more than 10 million people in the U.S., and is a common, chronic, and recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often in areas of the body with oil-producing (sebaceous) glands, including the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back.

“The acceptance of the NDA for roflumilast foam marks a major milestone toward our goal of bringing a steroid-free, topical foam treatment option to market, addressing a significant unmet need for individuals living with seborrheic dermatitis,” said Frank Watanabe, President and CEO of Arcutis. “If approved, roflumilast foam would be the first topical drug with a new mechanism of action for this condition in over two decades, highlighting the unique formulation and deep dermatological expertise that Arcutis brings to immuno-dermatology. We look forward to continuing our work with the FDA over the coming months and are preparing commercial efforts for the anticipated approval and launch.”

The NDA is supported by positive results from Arcutis’ Phase 2 and pivotal Phase 3 trials in seborrheic dermatitis. The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) was the pivotal Phase 3, parallel group, double-blind, vehicle-controlled study evaluating the safety and efficacy of roflumilast foam 0.3% in seborrheic dermatitis. The STRATUM study met its primary endpoint with an Investigator Global Assessment (IGA) Success rate of 79.5% in roflumilast foam-treated individuals compared to 58.0% (P<0.0001) in those treated with vehicle at Week 8. Improvement with roflumilast foam was seen early, with roflumilast demonstrating a statistically significant improvement compared to vehicle on IGA Success at Week 2, the first timepoint assessed. In addition, 51.3% of individuals in the roflumilast foam treated arm reached complete clearance at Week 8.

The study also demonstrated statistically significant improvement over vehicle on all secondary endpoints, including itch, scaling, and erythema (redness). More than 60% of individuals achieved an itch response at Week 8 (62.8% roflumilast foam vs 40.6% vehicle; p=0.0001), and significant improvements in itch were reported at Week 2 and Week 4.

Roflumilast foam was well-tolerated with a favorable safety and tolerability profile. Incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. There were no treatment-related Serious Adverse Events (SAEs). In the combined Phase 2 and Phase 3 studies, over 90% of patients who were randomized to roflumilast foam in the study completed the full eight weeks of treatment, and there were few discontinuations due to adverse events (0.9% and 2.2% in the roflumilast foam and vehicle groups, respectively). Overall, the most common adverse events occurring in ≥1% of subjects in the combined phase 2 and phase 3 study populations included nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).   

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 foam is a once-daily foam formulation of roflumilast which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.

Roflumilast cream 0.3% (ZORYVE^®) is approved by the FDA for the topical treatment of plaque psoriasis in adults and adolescents.

About ZORYVE
ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION
The use of 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%), headache (2%), insomnia (1%), nausea (1%), application site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).

Please see full Prescribing Information.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early commercial-stage 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 Twitter.

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 and timing for roflumilast foam to be approved by the FDA for the treatment of adults and adolescents with seborrheic dermatitis, the potential to use roflumilast foam over a long period of time, or chronically, the potential to use roflumilast foam anywhere on the body, including the face and scalp, and the potential for roflumilast foam to advance the standard of care in seborrheic dermatitis and other inflammatory dermatological conditions. 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