Positive results from the global COAST 1 phase 3 study (clinical study identifier:

全球COAST 1第3阶段研究（临床研究标识符：

NCT06130566

NCT06130566

) showed that amlitelimab, a fully human non-T cell depleting monoclonal antibody that targets OX40-ligand (OX40L), dosed either every four weeks (Q4W) or every 12 weeks (Q12W), met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful skin clearance and disease severity compared to placebo at Week 24 in patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD).

) 显示，每四周 (Q4W) 或每 12 周 (Q12W) 给药的全人源非 T 细胞耗竭单克隆抗体 amitelimab（靶向 OX40 配体 (OX40L)），达到了所有主要和关键次要终点，在 12 岁及以上中度至重度特应性皮炎 (AD) 患者中，与安慰剂相比，在第 24 周显示出统计学显著性和临床意义上的皮肤清除和疾病严重程度改善。

Amlitelimab was well-tolerated, with no new safety concerns identified in this study..

Amlitelimab 耐受性良好，本研究中未发现新的安全性问题。

“These positive first phase 3 results of amlitelimab reinforce the potential of targeting the OX40-ligand to normalize the overactive immune system, without depleting T cells,”

“这些关于amlitelimab的三期临床试验的积极初步结果证实了靶向OX40配体以调节过度活跃的免疫系统的潜力，且不会耗竭T细胞。”

said

说

Houman Ashrafian

侯曼·阿什拉菲安

, Executive Vice President, Head of Research & Development at Sanofi.

执行副总裁，赛诺菲研发部门负责人。

“Amlitelimab may represent a significant advance in the treatment of atopic dermatitis with clinically meaningful and progressively increasing efficacy, with the potential of dosing only four times per year. These promising data seen in a study population that more closely resembles today’s diverse patient landscape, including a substantial proportion previously treated with advanced therapies, support our ambition to deliver a differentiated medicine.

“Amlitelimab 可能代表了特应性皮炎治疗的重大进步，其临床意义重大且疗效逐步提高，每年仅需给药四次。在研究人群中观察到的这些令人鼓舞的数据更贴近当今多样化的患者群体，其中包括很大比例曾接受过先进治疗的患者，这支持了我们提供一种差异化药物的雄心。”

We look forward to sharing additional phase 3 results from the OCEANA clinical development program.”.

我们期待分享OCEANA临床开发项目的更多第3阶段结果。

The key endpoints were measured at Week 24 in patients who received amlitelimab either Q4W or Q12W. For US and US reference countries, the primary endpoint was the proportion of patients with a validated investigator global assessment scale for AD (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline score of ≥2 points.

关键终点是在接受每4周（Q4W）或每12周（Q12W）amitelimab治疗的患者中于第24周测量的。对于美国及美国参考国家，主要终点是验证的特应性皮炎研究者总体评估量表（vIGA-AD）评分达到0（清除）或1（几乎清除）且较基线评分减少≥2分的患者比例。

For the EU, EU reference countries and Japan, the co-primary endpoints comprised the proportion of patients with vIGA-AD 0/1 and a reduction from baseline score of ≥2 points along with the proportion of patients reaching a 75% or greater improvement in the eczema area and severity index total score (EASI-75)..

对于欧盟、欧盟参考国家和日本，共同主要终点包括达到vIGA-AD 0/1的患者比例以及基线评分减少≥2分的患者比例，同时还有达到湿疹面积和严重程度指数总评分（EASI-75）改善75%或以上的患者比例。

Key endpoints

关键端点

Proportion of patients

患者比例

Non-responder imputation*

无应答者填补*

Treatment policy**

治疗政策**

Q4W

Q4W

Q12W

Q12W

Placebo

安慰剂

Q4W

第四季度

Q12W

Q12W

Placebo

安慰剂

vIGA-AD 0/1

vIGA-AD 0/1

21.1%

21.1%

p-value (p) <0.01

p值 (p) <0.01

22.5%

22.5%

p <0.01

p <0.01

9.2%

9.2%

26.5%

26.5%

p <0.001

p <0.001

29.1%

29.1%

p <0.001

p <0.001

10.5%

10.5%

EASI-75

EASI-75

35.9%

35.9%

p <0.001

p <0.001

39.1%

39.1%

p <0.001

p <0.001

19.1%

19.1%

46.0%

46.0%

p <0.001

p <0.001

50.3%

50.3%

p <0.001

p <0.001

27.6%

27.6%

* Non-responder imputation: includes patients with rescue/prohibited medication use prior to Week 24 and missing data.

* 无应答者填补：包括在第24周前使用补救/禁用药物的患者及缺失数据。

** Treatment policy: includes data for patients with rescue medication use prior to Week 24. Note: In both analyses non-responder imputation for patients with prohibited medication use and missing data.

** 治疗政策：包括第24周前使用救援药物的患者数据。注意：在两种分析中，对使用禁用药物和数据缺失的患者均采用非应答者填补法。

In both treatment arms, a progressive increase in efficacy without plateau was observed during the treatment period:

在两个治疗组中，在治疗期间均观察到疗效逐步提高且没有出现平台期：

(Treatment effects at Week 24 are modeled and do not reconcile with the table).

（第24周的治疗效果是模拟的，与表格数据不一致）。

The study’s key secondary endpoints were also achieved across both dosing arms at Week 24, including the proportion of patients who achieved a vIGA-AD 0/1 with only barely perceptible erythema and a reduction from baseline of ≥2-points, and the proportion of patients who achieved a ≥4-point reduction in peak pruritus-numerical rating scale (PP-NRS) from baseline in patients with a baseline PP-NRS ≥4..

该研究的次要终点在第24周时也在两个剂量组中达成，包括达到vIGA-AD 0/1（仅有勉强可察觉的红斑）且较基线减少≥2分的患者比例，以及基线PP-NRS≥4的患者中达到峰值瘙痒数值评定量表（PP-NRS）较基线减少≥4分的患者比例。

The most common treatment emergent adverse events (TEAEs) in COAST 1 (≥5% in any dose arm) were AD, nasopharyngitis and upper respiratory tract infection. All were more common in the placebo arm compared to amlitelimab-treated arms. Injection site reactions were numerically higher in amlitelimab arms (pooled amlitelimab 2.2%, placebo 0.7%).

COAST 1中最常见的治疗中出现的不良事件（TEAEs）（在任何剂量组中≥5%）为AD、鼻咽炎和上呼吸道感染。所有这些事件在安慰剂组中比在氨替利单抗治疗组中更为常见。注射部位反应在氨替利单抗组中数值较高（汇总氨替利单抗组2.2%，安慰剂组0.7%）。

All were mild, patients recovered, and study medication was continued in all cases. Rates of pyrexia (1.1% in pooled amlitelimab arms vs. 0.7% in placebo arm) and chills (0.4% in pooled amlitelimab arms vs. 0% in placebo arm) were low. Overall, rates of treatment-emergent adverse events (TEAEs), serious adverse events, and TEAEs resulting in treatment discontinuation were similar in the placebo arm and pooled amlitelimab arms..

所有反应均较轻微，患者均已恢复，并且在所有情况下研究药物均继续使用。发热率（汇总的amlitelimab组为1.1%，安慰剂组为0.7%）和寒颤率（汇总的amlitelimab组为0.4%，安慰剂组为0%）较低。总体而言，治疗中出现的不良事件（TEAEs）、严重不良事件以及导致治疗中断的TEAEs的发生率在安慰剂组和汇总的amlitelimab组中相似。

Full results will be submitted for presentation at a forthcoming medical meeting.

完整结果将提交给即将召开的医学会议进行展示。

The OCEANA clinical development program of amlitelimab in AD, which includes COAST 1 and four other phase 3 studies (SHORE, COAST 2, AQUA, and ESTUARY) is anticipated to read out through 2026 and comprises the foundation for potential global regulatory submissions.

Amlitelimab在特应性皮炎（AD）中的OCEANA临床开发项目，包括COAST 1和另外四项3期研究（SHORE、COAST 2、AQUA和ESTUARY），预计将在2026年之前取得结果，并为潜在的全球监管提交奠定基础。

Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Amlitelimab目前正处于临床研究阶段，其安全性和有效性尚未由任何监管机构评估。

About the COAST 1 study

关于COAST 1研究

COAST 1 was a randomized, double-blind, placebo-controlled, parallel-group, 3-arm, global, multicenter phase 3 study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in 601 adults and adolescents aged 12 years and older with moderate-to-severe AD. Key objectives included measuring the efficacy and safety of amlitelimab compared to placebo at Week 24.

COAST 1 是一项随机、双盲、安慰剂对照、平行分组、三臂、全球多中心的三期研究，旨在评估通过皮下注射给予氨立替利单抗单药治疗在601名12岁及以上中重度特应性皮炎（AD）的成人和青少年中的疗效和安全性。主要目标包括在第24周时比较氨立替利单抗与安慰剂的疗效和安全性。

In the study, amlitelimab was administered at a dose of 250 mg (125 mg for those with body weight <40 kg) on either a Q4W or Q12W schedule following a loading dose of 500 mg (250 mg for those with body weight <40 kg). The study included sites in 15 countries across North America, Latin America, Europe, Asia-Pacific and the Middle East, reflecting a diverse study population..

在该研究中，给予患者的阿姆利替单抗剂量为250毫克（体重小于40公斤的患者为125毫克），在给予500毫克的负荷剂量后（体重小于40公斤的患者为250毫克），按每4周一次或每12周一次给药。该研究覆盖了北美、拉丁美洲、欧洲、亚太地区和中东的15个国家的多个研究中心，反映了多样化的人群组成。

About amlitelimab

关于amlitelimab

Amlitelimab (SAR445229, KY1005) is a fully human, non-T cell depleting monoclonal antibody that blocks OX40L, a key immune regulator. With its novel mechanism of action, amlitelimab aims to normalize the overactive immune system, without depleting T cells. It has the potential to be a first- or best-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including the anchor indication of moderate-to-severe AD, and potentially in moderate-to-severe asthma, systemic sclerosis, celiac disease, and alopecia areata..

Amlitelimab（SAR445229，KY1005）是一种全人源、非T细胞耗竭的单克隆抗体，可阻断关键免疫调节因子OX40L。凭借其新颖的作用机制，Amlitelimab旨在使过度活跃的免疫系统恢复正常，而不会耗竭T细胞。它有潜力成为一系列免疫介导疾病和炎症性疾病的首创新药或最佳治疗药物，包括中重度特应性皮炎（AD）这一主要适应症，并可能用于中重度哮喘、系统性硬化症、乳糜泻和斑秃等疾病的治疗。

About Sanofi

关于赛诺菲

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time..

赛诺菲是一家以研发为驱动、以人工智能赋能的生物制药公司，致力于改善人们的生活并实现引人注目的增长。我们凭借对免疫系统的深刻理解，开发药物和疫苗，为全球数百万人提供治疗和保护，同时拥有一条创新的研发管线，未来有望使数百万人进一步受益。我们的团队秉承一个使命：追逐科学的奇迹以改善人们的生活；这激励我们通过应对当今最紧迫的医疗、环境和社会挑战，推动进步并为我们服务的人群和社区带来积极影响。