LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced positive results from its Phase 4, open-label clinical trial of VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in the head and neck region in adults (N=31)..

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，今天宣布其VTAMA®（tapinarof）乳膏的第四期开放标签临床试验取得了积极成果，该乳膏1%用于治疗成人头颈部斑块状牛皮癣（N=31）。。

“Up to 80% of patients with plaque psoriasis experience scalp psoriasis, making it one of the most affected areas of the body. In this Phase 4 trial, a majority of the adult patients suffered from scalp psoriasis, making the outcomes from this trial significant, as they further reinforce the efficacy, safety, tolerability, and cosmetic elegance of VTAMA cream even when used in hair bearing areas such as the head and neck region,” said Philip M.

“高达80%的斑块状银屑病患者患有头皮牛皮癣，使其成为身体受影响最严重的部位之一。在这项第4阶段试验中，大多数成年患者患有头皮牛皮癣，这使得该试验的结果具有重要意义，因为它们进一步增强了VTAMA霜的功效，安全性，耐受性和美观性，即使在毛发生长区域使用也是如此例如头颈部。

Brown, MD, JD, Chief Medical Officer at Dermavant. “The Phase 3 PSOARING studies and the Phase 4, open-label, intertriginous plaque psoriasis study combined with the Phase 4, open-label, head and neck data announced today, highlight the versatility of VTAMA cream, an efficacious, safe and well tolerated, non-steroidal treatment option for plaque psoriasis in all affected areas of the body.”.

布朗，医学博士，法学博士，Dermavant首席医疗官。“第三阶段银屑病研究和第四阶段开放标签三叉间斑块型银屑病研究结合今天公布的第四阶段开放标签头颈部数据，突出了VTAMA乳膏的多功能性，VTAMA乳膏是一种有效，安全且耐受性良好的非甾体类治疗选择，用于治疗身体所有受影响部位的斑块型银屑病。”。

This Phase 4, open-label study expands the body of data for VTAMA cream in adult plaque psoriasis. In the two 12-week Phase 3 pivotal studies (PSOARING 1 and 2; N=1025), VTAMA cream demonstrated a Physician Global Assessment (PGA) success rate* of 36% and 40% for adult patients with plaque psoriasis versus 6% for patients on vehicle at Week 12, respectively.

这项第四阶段的开放标签研究扩大了VTAMA乳膏在成人斑块型银屑病中的数据范围。在两项为期12周的3期关键研究（牛皮癣1和2；N=1025）中，VTAMA乳膏显示，斑块状银屑病成年患者的医生全球评估（PGA）成功率*分别为36%和40%，而12周时车辆上的患者分别为6%。

DMVT-505-4002 (NCT05789576) was a Phase 4, open-label multi-center study to investigate the efficacy and safety of VTAMA (tapinarof) cream, 1% for the treatment of adults with plaque psoriasis specifically in the head and neck region. The efficacy of VTAMA cream was assessed using a PGA evaluation of a target plaque psoriasis lesion in the head and neck region, Scalp n=18 (58.1%), Face n=11 (35.5%) and Neck n=2 (6.5%) identified at baseline.

DMVT-505-4002（NCT05789576）是一项4期开放标签多中心研究，旨在研究VTAMA（tapinarof）乳膏的疗效和安全性，1%用于治疗头颈部斑块状银屑病的成人。VTAMA乳膏的疗效使用PGA评估头颈部目标斑块牛皮癣病变，头皮n=18（58.1%），面部n=11（35.5%）和颈部n=2（6.5%）在基线时确定。

The trial enrolled 31 participants with mild, moderate, and severe head and neck plaque psoriasis (tPGA score ≥2) aged 18 years or older at 8 sites across the U.S. Patients received VTAMA cream once daily for 12 weeks with a follow up one week after study completion. Safety and tolerability were assessed by visit based on adverse events and local tolerability scores using the investigator-assessed Local Tolerability Scale (LTS) of the head and neck region and a Patient Satisfaction Questionnaire (PSQ) that was designed to assess patients’ satisfaction with VTAMA cream’s efficacy, formulation elegance, application ease, impact on daily life, and preference versus prior therapies..

该试验在美国8个地点招募了31名年龄在18岁或以上的轻度，中度和重度头颈部斑块型银屑病（tPGA评分≥2）参与者。患者每天一次接受VTAMA乳膏治疗12周，研究完成后一周进行随访。使用研究者评估的头颈部局部耐受性量表（LTS）和患者满意度问卷（PSQ），根据不良事件和局部耐受性评分，通过访视评估安全性和耐受性，该问卷旨在评估患者对VTAMA乳膏的疗效，配方优雅，应用方便性，对日常生活的影响，和偏好与先前的治疗相比。。

The primary endpoint of the study was the proportion of adult patients who achieved a tPGA score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12 (tPGA Success). The secondary endpoint of the study was the time to achieve tPGA Success. Additional exploratory endpoints of the study included ≥75% improvement in PASI, change from baseline in Peak Pruritus-Numeric Rating Scale (PP-NRS), ≥4point reduction in PP-NRS, and improvement in DLQI.

该研究的主要终点是在第12周（tPGA成功）时，tPGA评分达到0（清晰）或1（几乎清晰）且从基线改善≥2级的成年患者比例。该研究的次要终点是实现tPGA成功的时间。该研究的其他探索性终点包括PASI改善≥75%，瘙痒峰值数字评定量表（PP-NRS）从基线变化，PP-NRS降低≥4分，以及DLQI改善。

Efficacy and PP-NRS assessments were specific to the head and neck region..

功效和PP-NRS评估是针对头部和颈部区域的。。

Phase 4 Results

第4阶段结果

Primary and Secondary Endpoints

主要和次要终点

VTAMA cream reinforced strong efficacy for the treatment of head and neck plaque psoriasis (PsO), with 88.5% of adult patients (n=23/26) achieving a tPGA Success score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12, the primary endpoint of the study.

VTAMA乳膏增强了治疗头颈部斑块型银屑病（PsO）的强大疗效，88.5%的成年患者（n=23/26）的tPGA成功评分为0（清晰）或1（几乎清晰），并且在研究的主要终点第12周从基线改善≥2级。

VTAMA cream showed a rapid onset of efficacy with tPGA Success achieved as early as Week 1 in some patients, with a median time of approximately 4 weeks, the secondary endpoint of the study.

VTAMA乳膏显示出快速起效，早在第1周，一些患者就取得了tPGA成功，中位时间约为4周，这是该研究的次要终点。

Additional Endpoints

其他端点

At Week 12, 80.8% (n=21/26) of adult patients achieved complete clearance of the target lesion (tPGA=0) which was observed as early as Week 1 and with a median time of 8 weeks.

在第12周，80.8%（n=21/26）的成年患者实现了目标病变的完全清除（tPGA=0），这早在第1周就观察到，中位时间为8周。

At Week 12, 96.2% (n=25/26) of patients achieved PASI75 (≥75% reduction in PASI of the head and neck region), with achievement observed as early as Week 1.

在第12周，96.2%（n=25/26）的患者达到了PASI75（头颈部PASI降低≥75%），早在第1周就观察到了这一成就。

Onset of itch relief was apparent as early as Week 1 and increased over time with 70% (n=14/20) of patients achieving a clinically meaningful ≥4-point improvement in PP-NRS at Week 12.

瘙痒缓解的发作早在第1周就很明显，并且随着时间的推移而增加，70%（n=14/20）的患者在第12周时PP-NRS的临床意义≥4点改善。

Substantial and clinically meaningful improvement in quality of life, as indicated by a 4-point improvement in DLQI, was achieved as early as Week 1 with further improvement out to Week 12.

生活质量的实质性和临床意义的改善，如DLQI的4点改善所示，早在第1周就实现了，并在第12周进一步改善。

As indicated on the Patient Satisfaction Questionnaire, 93.3% (n=28/30) of subjects strongly agreed or agreed that VTAMA cream was not greasy, 86.7% (n=26/30) of subjects strongly agreed or agreed that VTAMA cream was easy to apply, and 96.7% (n=29/30) of subjects strongly agreed or agreed that VTAMA cream absorbs quickly..

如患者满意度问卷所示，93.3%（n=28/30）的受试者强烈同意或同意VTAMA乳膏不油腻，86.7%（n=26/30）的受试者强烈同意或同意VTAMA乳膏易于使用，96.7%（n=29/30）的受试者强烈同意或同意VTAMA乳膏吸收迅速。。

Safety and Tolerability

安全性和耐受性

VTAMA cream was well tolerated with no new safety signals.

VTAMA乳膏耐受性良好，没有新的安全信号。

The most common adverse reactions (incidence ≥ 5%) in subjects treated with VTAMA cream were folliculitis, contact dermatitis, headache, sinusitis, and seborrheic keratosis.

用VTAMA乳膏治疗的受试者中最常见的不良反应（发生率≥5%）是毛囊炎，接触性皮炎，头痛，鼻窦炎和脂溢性角化病。

“Plaque psoriasis is a chronic condition with a significant negative impact on patients’ quality of life. The scalp region, in particular, is one of the most difficult areas to treat. Many currently available treatment options fail to offer sustained long-term relief due to lack of practical applicability to certain body areas and limitations on the duration of use,” said G.

“斑块状银屑病是一种慢性病，对患者的生活质量产生重大负面影响。尤其是头皮部位，是最难治疗的部位之一。由于缺乏对某些身体部位的实用性和使用时间的限制，目前许多可用的治疗方案无法提供持续的长期缓解，”G。

Michael Lewitt, MD, FAAD, Board-Certified Dermatologist, Illinois Dermatology Institute. “The impressive levels of efficacy achieved by VTAMA cream in the open-label trial, where 80% of adult patients achieved complete clearance of the target lesion, is highly encouraging for both patients with plaque psoriasis and their healthcare providers.

Michael Lewitt，医学博士，FAAD，伊利诺伊州皮肤病研究所董事会认证皮肤科医生。“VTAMA乳膏在开放标签试验中取得了令人印象深刻的疗效，其中80%的成年患者完全清除了目标病变，这对斑块型银屑病患者及其医疗保健提供者都是非常令人鼓舞的。

Importantly, 58% of patients enrolled in the trial had a target plaque psoriasis lesion in the scalp region, and as assessed by both the investigators and the patients in the trial, VTAMA cream demonstrated favorable tolerability even when applied in hair bearing affected areas; making it a versatile and cosmetically elegant treatment option for plaque psoriasis that can be used anywhere on the affected body areas, including the most sensitive areas as well the scalp, head, and neck areas.”.

重要的是，参加试验的患者中有58%在头皮区域有目标斑块牛皮癣病变，根据研究人员和试验患者的评估，VTAMA乳膏即使应用于毛发受影响的区域也表现出良好的耐受性；使其成为斑块状银屑病的多功能且美容优雅的治疗选择，可用于受影响身体部位的任何部位，包括最敏感的部位以及头皮，头部和颈部区域。”。

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。

On July 15, 2022, VTAMA cream became the #1 prescribed branded topical treatment for plaque psoriasis in adultsi and to date has over 250,000 prescriptions written by over 12,000 unique prescribers†..

2022年7月15日，VTAMA乳膏成为成人斑块状银屑病的#1处方品牌局部治疗药物，迄今为止，已有超过12000名独特处方者开出了超过250000张处方†。。

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

鼓励您向FDA报告处方药的负面副作用。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 Psoriasis

关于牛皮癣

Impacting approximately 8 million Americans and 125 million people worldwide, psoriasis is a complex autoimmune disease — meaning that the body’s immune system targets and attacks its own cells. Plaque psoriasis, also called psoriasis vulgaris, is the most common form and affects about 80% to 90% of people with psoriasis.

牛皮癣是一种复杂的自身免疫性疾病，影响着全球约800万美国人和1.25亿人，这意味着人体的免疫系统会靶向并攻击自己的细胞。斑块状银屑病，也称为寻常型银屑病，是最常见的形式，影响约80%至90%的银屑病患者。

In people with light skin, plaque psoriasis is characterized by raised, red or pink patches of skin with silvery-white scales. People with black or brown skin are more likely to have brown or violet-colored patches with silvery-white or gray scales. The scales can be itchy, painful, and disfiguring..

在皮肤较浅的人群中，斑块状银屑病的特征是皮肤上出现隆起的红色或粉红色斑块，并伴有银白色鳞片。黑色或棕色皮肤的人更容易出现棕色或紫色斑块，并伴有银白色或灰色鳞片。鳞片可能会发痒，疼痛和毁容。。

Psoriasis can begin at any age, but typically appears around 15 to 25 years of age and 50 to 60 years of age. The exact cause of psoriasis is not known, but risk factors and triggers may include genetics or a family history of psoriasis, as well as stress, smoking, heavy alcohol consumption and cold or dry weather conditions.

牛皮癣可以在任何年龄开始，但通常出现在15至25岁和50至60岁左右。牛皮癣的确切原因尚不清楚，但危险因素和触发因素可能包括牛皮癣的遗传或家族史，以及压力，吸烟，大量饮酒和寒冷或干燥的天气条件。

People with psoriasis are at an increased risk of developing other health conditions, including psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. In addition to physical symptoms, psoriasis can have a significant impact on a person’s quality of life and psychological health..

银屑病患者患其他健康状况的风险增加，包括银屑病关节炎、炎症性肠病、高血压、糖尿病、肥胖和抑郁症。除了身体症状外，牛皮癣还可能对一个人的生活质量和心理健康产生重大影响。。

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。

*PGA success: PGA score of 0 or 1 and ≥2-grade improvement from baseline at Week 12.

*PGA成功：在第12周，PGA评分为0或1，从基线改善≥2级。

iIQVIA National Prescription Audit (NPA) for the 3-month period ending 11/24/2023, reflecting estimates of real-world activity. All rights reserved.

iIQVIA国家处方审计（NPA），截至2023年11月24日的3个月期间，反映了对现实世界活动的估计。保留所有权利。

†IQVIA NPA for the period 5/20/22 to 11/24/2023, reflecting estimates of real-world activity. All rights reserved.

†22年5月20日至2023年11月24日期间的IQVIA NPA，反映了对现实世界活动的估计。保留所有权利。

©2023 Dermavant Sciences, Inc. All Rights Reserved. All trademarks are the property of Dermavant Sciences, GmbH.

©2023 Dermavant Sciences，Inc.保留所有权利。所有商标均为Dermavant Sciences，GmbH的财产。