LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced new positive efficacy and safety data from analyses of the company’s ADORING Phase 3 development program in atopic dermatitis (AD) with VTAMA® (tapinarof) cream, 1% in adults and children as young as 2 years old..

加利福尼亚州长滩和瑞士巴塞尔——（商业新闻短讯）——Dermavant Sciences是一家致力于开发和商业化免疫皮肤病创新疗法的生物制药公司，今天宣布了新的积极疗效和安全性数据，这些数据来自该公司对VTAMA®（tapinarof）乳膏治疗特应性皮炎（AD）的3期开发计划的分析，1%的成年人和2岁以下的儿童。。

VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant and steroid-free, topical cream for both acute treatment and long-term management of AD. VTAMA cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the U.S.

VTAMA乳膏是一种新型的芳烃受体激动剂，正在开发中，作为一种每日一次，美容优雅且无类固醇的局部乳膏，用于AD的急性治疗和长期管理。VTAMA乳膏目前被批准用于美国成年人斑块状银屑病的局部治疗。

and is the same strength and formulation being studied in the ADORING Phase 3 development program for AD..

与ADORING第三阶段AD开发计划中研究的强度和配方相同。。

ADORING 1 and ADORING 2 were two identical, double-blind, randomized, vehicle-controlled Phase 3 studies that evaluated the efficacy and safety of VTAMA cream, 1% in adults and pediatric patients down to 2 years old who had a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 (moderate) to 4 (severe) at baseline.

ADORING 1和ADORING 2是两项相同的，双盲，随机，媒介物对照的3期研究，评估了VTAMA乳膏的疗效和安全性，1%的成人和2岁以下的儿科患者在基线时有一个经过验证的研究者特应性皮炎全球评估（vIGA AD）评分为3（中度）至4（严重）。

ADORING 3 is an ongoing open-label, long-term extension study being conducted to evaluate the safety and efficacy of VTAMA cream, 1% in patients with AD for up to 48 weeks of total treatment. The ADORING 3 study, which consists of 728 patients in total, includes patients who previously completed ADORING 1, ADORING 2, or the Maximal Usage Pharmacokinetics (MUPK) study for AD.

ADORING 3是一项正在进行的开放标签长期扩展研究，旨在评估VTAMA乳膏的安全性和有效性，在AD患者中为1%，总治疗时间长达48周。ADORING 3研究共有728名患者，包括先前完成ADORING 1，ADORING 2或AD最大使用药代动力学（MUPK）研究的患者。

ADORING 3 also includes 76 directly enrolled pediatric patients who did not meet the criteria for enrollment in the ADORING 1 and ADORING 2 pivotal trials because their AD was either mild or too severe..

ADORING 3还包括76名直接登记的儿科患者，他们不符合ADORING 1和ADORING 2关键试验的登记标准，因为他们的AD要么轻微，要么太严重。。

Dermavant completed an interim analysis of data from ADORING 3. The company also completed a planned integrated analysis of data including 711 patients from ADORING 1, ADORING 2, ADORING 3 and the MUPK study who had a vIGA-AD score of 3 (moderate) or greater prior to any treatment with VTAMA cream. The data from these analyses will be included in the company’s Supplemental New Drug Application (sNDA) submission to the U.S.

Dermavant完成了对ADORING 3数据的中期分析。该公司还完成了一项有计划的数据综合分析，包括711名来自ADORING 1，ADORING 2，ADORING 3和MUPK研究的患者，他们在使用VTAMA乳膏治疗之前的vIGA AD评分为3（中等）或更高。这些分析的数据将包含在该公司提交给美国的补充新药申请（sNDA）中。

Food and Drug Administration (FDA), expected in Q1 of 2024..

食品和药物管理局（FDA），预计2024年第一季度。。

Analyses of Efficacy Data

疗效数据分析

The integrated analysis across the ADORING development program showed that efficacy continued to improve beyond the 8-week double blind treatment period in ADORING 1 and ADORING 2 across multiple endpoints including:

整个ADORING发展计划的综合分析表明，在ADORING 1和ADORING 2的8周双盲治疗期之后，多个终点的疗效继续提高，包括：

vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline was observed in 73% (519/711) of patients included.

在73%（519/711）的患者中观察到vIGA AD评分为0（清晰）或1（几乎清晰），与基线相比至少有2级改善。

80.7% (574/711) of patients achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75).

80.7%（574/711）的患者湿疹面积和严重程度指数（EASI75）至少改善了75%。

77.9% (218/280) of patients ≥12 years old with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score ≥4 achieved a ≥4-point reduction in PP-NRS. In the ADORING pivotal studies, a mean itch reduction was observed as early as 24 hours after first application.

基线峰值瘙痒数字评定量表（PP-NRS）评分≥4的≥12岁患者中有77.9%（218/280）的PP-NRS降低了≥4分。在ADORING关键研究中，早在首次应用后24小时就观察到平均瘙痒减少。

92.3% (656/711) of patients achieved at least a 1-grade improvement in vIGA-AD score.

92.3%（656/711）的患者vIGA AD评分至少提高了1级。

The interim analysis of the ADORING 3 open-label, long-term extension study demonstrated that 51.2% (373/728) of patients achieved complete disease clearance (vIGA-AD score of 0).

ADORING 3开放标签长期扩展研究的中期分析表明，51.2%（373/728）的患者达到了完全的疾病清除率（vIGA AD评分为0）。

“In the analyses of the ADORING development program, approximately 81% of the patient population in the integrated analysis achieved EASI75 using VTAMA cream, and approximately 51% of patients in ADORING 3, including both adults and children as young as 2 years old, achieved complete disease clearance with a vIGA-AD score of 0,” said Philip Brown, M.D., J.D., Chief Medical Officer of Dermavant.

“在ADORING发展计划的分析中，综合分析中约81%的患者使用VTAMA乳膏达到EASI75，ADORING 3中约51%的患者（包括成年人和2岁以下的儿童）达到了完全的疾病清除率，vIGA AD评分为0，”医学博士菲利普·布朗说。，Dermavant首席医疗官。

“Importantly, in addition to the efficacy data reported today, no new safety signals were observed, further supporting VTAMA cream’s clinical profile and its potential ability to achieve long-term disease control.”.

“重要的是，除了今天报道的疗效数据外，没有观察到新的安全信号，进一步支持了VTAMA乳膏的临床特征及其实现长期疾病控制的潜在能力。”。

Dr. Brown continued, “Turning to long-term disease management, the ADORING 3 study design dictated that when patients achieved complete disease clearance (vIGA-AD score of 0), VTAMA cream was withdrawn and patients were monitored until their AD flared to mild (vIGA-AD ≥2). While the ability for a topical monotherapy to achieve complete disease clearance in over 50% of the patient population is significant, we also observed that those patients were able to maintain an extended period of flare-free days off therapy— i.e., a ‘remittive effect’ – potentially giving patients the ability to safely manage and have control over their disease on a long-term basis without the need for daily or intermittent use of VTAMA cream.

布朗博士继续说道，“转向长期疾病管理，ADORING 3研究设计规定，当患者达到完全疾病清除（vIGA AD评分为0）时，VTAMA乳膏被撤回，并对患者进行监测，直到其AD发作至轻度（vIGA AD≥2）。虽然局部单一疗法在超过50%的患者人群中实现完全疾病清除的能力是显着的，但我们还观察到这些患者能够维持较长时间的无眩晕休息日-即。，“缓解效应”-可能使患者能够长期安全管理和控制疾病，而无需每天或间歇性使用VTAMA乳膏。

Overall, we are highly encouraged by the data from the ADORING development program to date and believe that, if approved by the FDA, VTAMA cream may help address a significant unmet need as an important steroid-free, topical treatment option for millions of patients who suffer from atopic dermatitis, including both adults and children as young as 2 years old.”.

总的来说，我们对ADORING development program迄今为止的数据感到非常鼓舞，并相信，如果FDA批准，VTAMA乳膏可能有助于解决严重未满足的需求，作为数百万患有特应性皮炎的患者的重要无类固醇局部治疗选择，包括成年人和2岁以下的儿童。”。

ADORING 3 Interim Analysis Safety Data

ADORING 3中期分析安全数据

VTAMA cream, 1% was well-tolerated across all treated areas, including sensitive skin and intertriginous locations, as assessed by both patients and investigators.

根据患者和研究人员的评估，VTAMA乳膏在所有治疗部位（包括敏感皮肤和三叉间部位）的耐受性均为1%。

No new safety signals were observed with long-term use. The study discontinuation rate in ADORING 3 due to adverse events (AEs) was 2.6% (19/728).

长期使用未观察到新的安全信号。ADORING 3因不良事件（AE）导致的研究中断率为2.6%（19/728）。

The majority of AEs were mild to moderate in nature with the most commonly reported AEs in ADORING 3 being folliculitis, nasopharyngitis and upper respiratory tract infection.

大多数AE本质上是轻度至中度的，ADORING 3中最常见的AE是毛囊炎，鼻咽炎和上呼吸道感染。

There were no treatment-related serious adverse events (SAEs) reported.

没有报告与治疗相关的严重不良事件（SAE）。

“Atopic dermatitis is a burdensome disease, especially for pediatric patients, the most frequently affected patient population. The integrated analysis data from the ADORING development program are particularly encouraging as they show a high level of efficacy in a diverse patient population, including patients down to 2 years of age, who are in need of a treatment option such as VTAMA cream that has demonstrated a positive safety and tolerability profile and potential long-term disease control in the ADORING studies,” said Eric Simpson, MD, MCR, the Frances J.

“特应性皮炎是一种负担沉重的疾病，尤其是对儿科患者来说，儿科患者是受影响最频繁的患者群体。ADORING发展计划的综合分析数据特别令人鼓舞，因为它们在不同的患者群体中显示出高水平的疗效，包括2岁以下的患者，他们需要治疗选择，如VTAMA乳膏that在ADORING研究中显示出积极的安全性和耐受性以及潜在的长期疾病控制，”Eric Simpson说，医学博士，MCR，the Frances J。

Storrs Medical Dermatology Professor and Director of CLEAR Eczema Center, at the Oregon Health & Science University. “If approved for the treatment of atopic dermatitis, VTAMA cream’s efficacy and safety profile combined with its rapid onset of itch reduction, the most common symptom of atopic dermatitis, could provide an important new treatment option for not only patients suffering from the disease but also for their caregivers and the healthcare professionals treating them.”.

俄勒冈州健康与科学大学斯托尔斯医学皮肤病学教授兼CLEAR湿疹中心主任。“如果被批准用于治疗特应性皮炎，VTAMA乳膏的功效和安全性以及特应性皮炎最常见的症状瘙痒的快速发作，不仅可以为患有该疾病的患者提供重要的新治疗选择，而且可以为他们的护理人员和治疗他们的医疗保健专业人员提供新的治疗选择。”。

“The highly encouraging data reported today is a significant milestone for patients suffering with atopic dermatitis and their families, and I am extremely thankful to all the patients, their families, and the investigators involved in the ADORING development program,” said Todd Zavodnick, Chief Executive Officer of Dermavant.

Dermavant首席执行官托德·扎沃德尼克（ToddZavodnick）表示：“今天报道的令人鼓舞的数据对于患有特应性皮炎的患者及其家人来说是一个重要的里程碑，我非常感谢所有患者、他们的家人以及参与ADORING development program的研究人员。”。

“We are focused on compiling our sNDA data for submission that is expected in Q1 of 2024 and we look forward to making VTAMA cream, 1% available as a potential treatment option for both adults and children suffering from atopic dermatitis as expeditiously as possible, subject to regulatory approval.”.

“我们专注于汇编我们的sNDA数据，预计将于2024年第一季度提交，我们期待着尽快为患有特应性皮炎的成人和儿童提供1%的VTAMA乳膏作为潜在的治疗选择，并获得监管部门的批准。”。

On May 24, 2022, Dermavant announced that the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults. The approval made VTAMA cream the first non-steroidal topical novel chemical entity launched for plaque psoriasis in the U.S. in more than 25 years. VTAMA cream 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..

2022年5月24日，Dermavant宣布FDA批准VTAMA®（tapinarof）乳膏，1%用于治疗成人斑块状银屑病。该批准使VTAMA乳膏成为25年多来美国首个针对斑块状银屑病推出的非甾体外用新型化学实体。VTAMA霜被批准用于轻度，中度和重度斑块状牛皮癣-没有标签安全警告或预防措施，对使用时间或体表面积有限制。。

IMPORTANT SAFETY INFORMATION

重要安全信息

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)..

适应症：VTAMA®（tapinarof）乳膏，1%是一种芳烃受体激动剂，用于局部治疗成人斑块状银屑病。不良事件：用VTAMA乳膏治疗的受试者中最常见的不良反应（发生率≥1%）是毛囊炎（毛孔周围红肿），鼻咽炎（鼻子和喉咙疼痛或肿胀），接触性皮炎（皮疹或刺激，包括瘙痒和发红，脱皮，灼热或刺痛），头痛，瘙痒（瘙痒）和流感（流感）。。

You are encouraged to report negative side effects of prescription drugs to the FDA.

鼓励您向FDA报告处方药的负面副作用。

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

访问www.fda.gov/medwatch或致电1-800-fda-1088。

See full Prescribing Information and Patient Information.

请参阅完整的处方信息和患者信息。

About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis

关于Dermavant针对特应性皮炎的VTAMA乳膏的第三阶段计划

ADORING is Dermavant’s pivotal Phase 3 atopic dermatitis (AD) clinical development 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.

ADORING是Dermavant针对VTAMA®（tapinarof）乳膏的关键性3期特应性皮炎（AD）临床开发计划，占1%，其中包括ADORING 1（NCT05014568）和ADORING 2（NCT05032859），以及ADORING 3（NCT05142774），这是一项为期48周的开放标签长期扩展研究。

About Atopic Dermatitis

关于特应性皮炎

Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affects 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 20% 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.

特应性皮炎（AD），通常称为湿疹，是最常见的炎症性皮肤病之一，仅在美国就有2600多万人受到影响，全世界成年人中就有10%受到影响。AD最常发生在儿童中，影响全球高达20%。这种疾病会导致皮肤发痒、发红、肿胀和破裂，通常会影响手臂的褶皱、膝盖的背部、手、脸和脖子。

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..

在AD中，瘙痒是一种特别令人烦恼的症状，并且在夜间会恶化，扰乱睡眠并引起疲劳，这可能导致儿童在学校注意力不集中。AD患者也可能由于疾病的可见度和不适而经历社交和情绪困扰。。

About Dermavant

关于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.

Dermavant Sciences是Roivant Sciences的子公司，是一家生物制药公司，致力于开发和商业化免疫皮肤病学的创新疗法。Dermavant的重点是开发有潜力解决高度未满足的医疗需求的疗法，同时提高研究和临床开发的效率。

The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized 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.

该公司的医疗皮肤病学渠道包括早期开发，晚期和商业化的候选产品，这些产品针对两个增长最大的免疫皮肤病市场，斑块状牛皮癣和特应性皮炎以及其他免疫和炎症疾病的特定未满足需求。

Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant is also developing VTAMA cream for the treatment of atopic dermatitis in adults and children as young as 2 years old and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023.

Dermavant正在销售1%的VTAMA®（tapinarof）乳膏，用于局部治疗成人斑块状牛皮癣。2022年5月，FDA批准VTAMA乳膏用于局部治疗轻度，中度和重度斑块状牛皮癣。Dermavant还开发了VTAMA乳膏，用于治疗2岁以下的成人和儿童的特应性皮炎，并于2023年上半年发布了其1期和2期关键性3期临床试验的阳性结果。

Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential treatment option for immunological and inflammatory diseases with multiple potential routes of administration..

Dermavant的管道包括DMVT-506，这是一种正在开发的下一代芳烃受体（AhR）激动剂，可作为多种潜在给药途径的免疫和炎症性疾病的潜在治疗选择。。

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

有关更多信息，请访问www.dermavant.com，并通过X（@dermavant）和LinkedIn（dermavant Sciences）关注我们。

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

有关更多信息，请访问https://www.dermavant.com/and在Twitter（@dermavant）和LinkedIn（dermavant Sciences）上关注我们。

©2024 Dermavant Sciences, Inc. All Rights Reserved. Dermavant and VTAMA are the registered trademarks of Dermavant Sciences, GmbH. vIGA-AD is the trademark of Eli Lilly and Co.

©2024 Dermavant Sciences，Inc.保留所有权利。Dermavant和VTAMA是Dermavant Sciences，GmbH的注册商标。vIGA AD是礼来公司的商标。