Sanofi’s respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD

赛诺菲的呼吸系统药物研发管线在哮喘领域取得新进展，并计划开展针对慢性阻塞性肺疾病（COPD）的新临床研究。

New phase 2 data for amlitelimab show efficacy in heterogeneous inflammatory asthma

Amli替利单抗的第二阶段新数据显示对异质性炎症性哮喘有效

Lunsekimig now targeting chronic rhinosinusitis and COPD in addition to asthma

朗塞基米现在除了针对哮喘，还针对慢性鼻窦炎和慢性阻塞性肺疾病（COPD）。

Itepekimab expanding into chronic rhinosinusitis along with COPD and bronchiectasis; phase 3 readouts in COPD in H2 2025 and bronchiectasis in 2026

Itepekimab正在扩展到慢性鼻窦炎、慢性阻塞性肺病（COPD）和支气管扩张症的治疗；预计在2025年下半年获得COPD的3期临床数据，2026年获得支气管扩张症的数据。

Paris, April 15, 2025.

巴黎，2025年4月15日。

Sanofi today shared new progress from its mid- to late-stage respiratory pipeline, including preliminary phase 2 results for amlitelimab in adults with moderate-to-severe asthma.

赛诺菲今天分享了其中晚期呼吸系统管线的新进展，包括amlitelimab在中重度哮喘成人中的初步二期结果。

Amlitelimab: clinically meaningful efficacy in asthma

Amlitelimab：在哮喘治疗中具有临床意义的疗效

Preliminary results from the TIDE-Asthma phase 2 study (clinical study identifier: NCT05421598) show that the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose level, leading to nominal significance at the medium and low doses. However, the study demonstrates amlitelimab's compelling efficacy in heterogeneous inflammatory asthma, potentially representing a breakthrough for this underserved patient population if observed in later studies.

TIDE-Asthma 2期研究（临床研究标识符：NCT05421598）的初步结果显示，在最高剂量水平上，第48周的年化加重率这一主要终点未达到，但在中剂量和低剂量下显示出名义显著性。然而，该研究证明了amlitelimab在异质性炎症性哮喘中的显著疗效，如果在后续研究中得到验证，可能代表了服务不足的患者群体的一项突破。

Treatment with amlitelimab led to nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose tested and a numerically greater reduction in exacerbations at the high dose at week 60. The study also demonstrated nominally significant and clinically meaningful improvement in secondary endpoints of lung function and asthma control.

使用amlitelimab治疗在中剂量测试中导致哮喘发作名义上显著且有临床意义的减少，在高剂量下第60周时发作减少更为明显。研究还表明，肺功能和哮喘控制的次要终点指标也出现了名义上显著且具有临床意义的改善。

Notably, in a patient sub-group defined by biomarkers (eosinophils ≥300 cells/ml and elevated neutrophils), amlitelimab showed nominally significant and clinically meaningful improvements in exacerbations (with a reduction of more than 70%), lung function and asthma control at week 60. These results demonstrate that amlitelimab has potential to improve key disease outcomes in asthma patients with continued unmet need.

值得注意的是，在由生物标志物定义的患者亚组中（嗜酸性粒细胞 ≥300 个细胞/ml 且中性粒细胞升高），安利单抗在第 60 周时表现出在恶化率（减少超过 70%）、肺功能和哮喘控制方面名义上显著且具有临床意义的改善。这些结果表明，安利单抗有潜力改善仍存在未满足需求的哮喘患者的关键疾病结果。

The phase 3 program is currently being planned..

第3阶段的计划目前正在规划中。

Houman Ashrafian

侯曼·阿什拉菲安

Executive Vice President, Head of Research & Development

执行副总裁，研发部门主管

“We are pleased by the significant progress we have made with our pipeline across respiratory indications. In asthma, amlitelimab shows potential as an effective, long-acting medicine, including in patients with moderate-to-severe heterogenous inflammation. If the preliminary effect we have seen is confirmed in phase 3 studies, amlitelimab could become a differentiated treatment option in asthma.

“我们很高兴我们在呼吸系统适应症的管线方面取得了重大进展。在哮喘领域，Amlitelimab显示出作为一种有效、长效药物的潜力，包括在中重度异质性炎症患者中的应用。如果我们在第三阶段研究中证实了初步效果，Amlitelimab可能成为哮喘治疗中的一个差异化选择。

These data validate our strategy to advance innovative science and provide new solutions for patients with challenging-to-treat respiratory diseases.”.

这些数据验证了我们推进创新科学的战略，并为难以治疗的呼吸系统疾病患者提供新的解决方案。”

Amlitelimab has a unique non-depleting mechanism of action targeting OX40-Ligand with the potential to durably restore immune balance, with a sustained effect and infrequent dosing. In the TIDE-Asthma study, patients were treated every four weeks for the first 24 weeks and every 12 weeks for the remaining 36 weeks.

Amlitelimab 具有独特的非耗竭作用机制，靶向 OX40 配体，有望持久恢复免疫平衡，效果持续且用药频率低。在 TIDE-Asthma 研究中，患者前 24 周每四周接受一次治疗，剩余 36 周每 12 周接受一次治疗。

The durable efficacy shown by amlitelimab through 60 weeks of treatment supports a quarterly maintenance dosing schedule. The safety profile was consistent with previous studies across indications, with no new safety signals identified throughout the 60-week treatment period. The incidence of treatment emergent adverse effects (TEAEs) or treatment discontinuation was similar between the amlitelimab and the placebo groups.

通过60周的治疗，amlitelimab显示的持久疗效支持每季度一次的维持剂量计划。其安全性与之前在各适应症中的研究一致，在整个60周的治疗期间未发现新的安全性问题。amlitelimab组和安慰剂组之间出现的治疗相关不良反应（TEAEs）或治疗中断的发生率相似。

The most frequent TEAEs (≥ 5% in any arm) more common (≥ 1%) than placebo were COVID-19, bronchitis, acute sinusitis and headache. All were mild-to-moderate in severity and all non-serious..

最常见的TEAE（任何组中≥5%）比安慰剂更常见（≥1%）的为COVID-19、支气管炎、急性鼻窦炎和头痛。所有症状均为轻至中度严重程度，且均不严重。

Full and final results will be presented at a forthcoming medical meeting.

完整和最终结果将在即将召开的医学会议上公布。

Lunsekimig: potential for broader use in chronic obstructive pulmonary disease

伦塞kimig：在慢性阻塞性肺疾病中具有更广泛应用的潜力

(COPD)

慢性阻塞性肺疾病 (COPD)

Lunsekimig is being explored in a broad population of asthma patients, regardless of their inflammation and severity status.

朗塞金单抗正在广泛的哮喘患者群体中进行探索，不论其炎症和严重程度状态如何。

The readout of the AIRCULES phase 2 study (clinical study identifier: NCT06102005) in moderate to severe asthma is anticipated in 2026 while the AIRLYMPUS phase 2 study (clinical study identifier: NCT06676319) in high-risk asthma was initiated in Q4 2024.

预计中重度哮喘的AIRCULES二期研究（临床研究标识符：NCT06102005）结果将在2026年公布，而高风险哮喘的AIRLYMPUS二期研究（临床研究标识符：NCT06676319）于2024年第四季度启动。

The readout of the phase 2 study in patients with chronic rhinosinusitis with nasal polyps (clinical study identifier: NCT06454240) is anticipated in 2026.

预计慢性鼻窦炎伴鼻息肉患者二期研究（临床研究标识符：NCT06454240）的结果将在2026年公布。

A phase 2/3 study in COPD is anticipated to begin in 2025.

预计将于2025年开始一项针对COPD的2/3期研究。

Itepekimab: expanding clinical studies beyond COPD into chronic rhinosinusitis

Itepekimab：将临床研究从慢性阻塞性肺病扩展到慢性鼻窦炎

In partnership with Regeneron, two phase 3 studies in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), CEREN 1 (clinical study identifier: NCT06834347) and CEREN 2 (clinical study identifier: NCT06834360) and one phase 2 study in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) (clinical study identifier: NCT06691113) were initiated in Q1 2025..

与再生元合作，针对慢性鼻窦炎伴鼻息肉（CRSwNP）患者的两项III期研究CEREN 1（临床研究标识符：NCT06834347）和CEREN 2（临床研究标识符：NCT06834360），以及针对慢性鼻窦炎不伴鼻息肉（CRSsNP）患者的一项II期研究（临床研究标识符：NCT06691113），于2025年第一季度启动。

Itepekimab is currently being explored in patients with COPD in two phase 3 studies AERIFY-1 (clinical study identifier: NCT04701983) and AERIFY-2 (clinical study identifier: NCT04751487) with the readout anticipated in H2 2025, and in one phase 2 study, AERIFY-3 (clinical study identifier: NCT05326412), with the readout anticipated in H2 2025..

目前，Itepekimab正在两项三期临床研究AERIFY-1（临床研究标识符：NCT04701983）和AERIFY-2（临床研究标识符：NCT04751487）中对慢性阻塞性肺疾病（COPD）患者进行探索，预计将在2025年下半年得到结果；此外还有一项二期临床研究AERIFY-3（临床研究标识符：NCT05326412），同样预计在2025年下半年获得结果。

Finally, itepekimab is being explored in a phase 2 study (clinical study identifier: NCT06280391) in bronchiectasis, with the readout anticipated in 2026.

最后，itepekimab正在一项二期研究（临床研究标识符：NCT06280391）中被探索用于支气管扩张症，预计结果将在2026年公布。

About amlitelimab

关于amlitelimab

Amlitelimab is a fully human non-T cell depleting monoclonal antibody that blocks OX40-Ligand, a key immune regulator, and has the potential to be a first- or best-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis (phase 3), asthma (phase 2), hidradenitis suppurativa (phase 2), systemic sclerosis (phase 2), celiac disease (phase 2), and alopecia (phase 2).

Amlitelimab 是一种完全人源化的非T细胞耗竭单克隆抗体，可阻断关键免疫调节因子OX40配体，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（3期）、哮喘（2期）、化脓性汗腺炎（2期）、系统性硬化症（2期）、乳糜泻（2期）和脱发（2期）。

By targeting OX40-Ligand, amlitelimab aims to preserve the balance between pro-inflammatory and regulatory T cells. Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority..

通过靶向OX40配体，amlitelimab旨在保持促炎和调节性T细胞之间的平衡。Amlitelimab目前正在临床研究中，其安全性和有效性尚未由任何监管机构评估。

About TIDE-Asthma

关于TIDE-哮喘

The phase 2 TIDE-Asthma study is a randomized, double-blind, placebo-controlled, dose-ranging study, evaluating amlitelimab as an add-on therapy in 437 adults with moderate-to-severe asthma. Participants were on standard-of-care medicines with medium-to-high doses of inhaled corticosteroids and up to two other controllers. The study included three dose levels of amlitelimab, each with a loading dose administered every four weeks for the first 24 weeks, followed by once every 12 weeks until week 60, with participants randomized 2:1:2:2 to receive one of the three active doses or placebo. The primary endpoint was the annualized rate of severe asthma exacerbations.

TIDE-Asthma二期研究是一项随机、双盲、安慰剂对照、剂量范围研究，评估了amlitelimab作为附加疗法在437名中重度哮喘成人患者中的效果。参与者使用标准治疗药物，包括中高剂量的吸入性糖皮质激素和最多两种其他控制药物。研究包括三个剂量水平的amlitelimab，每个剂量组均在前24周每四周给予一次负荷剂量，之后每12周一次直至第60周，参与者按2:1:2:2的比例随机分配接受三种活性剂量之一或安慰剂。主要终点是严重哮喘急性加重的年化发生率。

Key secondary endpoints include lung function (pre-BD FEV1) and asthma control (ACQ-5)..

关键的次要终点包括肺功能（支气管扩张前FEV1）和哮喘控制（ACQ-5）。

About lunsekimig

关于lunsekimig

Lunsekimig is a novel Nanobody VHH

Lunsekimig 是一种新型的纳米抗体 VHH

®

®

that combines targeting of IL13, a downstream cytokine causing tissue organ damage in respiratory diseases and TSLP, an upstream initiator of inflammation. Pre-clinical research suggests that the combination of these targets simultaneously can potentially lead to additive and synergistic benefits in immune-mediated diseases such as asthma.

结合了针对 IL13（一种在呼吸系统疾病中导致组织器官损伤的下游细胞因子）和 TSLP（一种炎症的上游启动因子）。临床前研究表明，同时针对这些靶点的组合可能会在诸如哮喘等免疫介导的疾病中带来叠加和协同效应的好处。

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

Lunsekimig目前正处于临床研究阶段，其安全性和有效性尚未经过任何监管机构的评估。

About itepekimab

关于itepekimab

In partnership with Regeneron, Sanofi is exploring itepekimab, a fully human monoclonal antibody that binds to and inhibits IL33, an initiator and amplifier of broad inflammation in respiratory diseases. Itepekimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority..

与再生元合作，赛诺菲正在研究依特匹单抗（itepekimab），这是一种全人源单克隆抗体，能够结合并抑制IL33——一种在呼吸系统疾病中引发并放大全局炎症的因子。依特匹单抗目前正处于临床研究阶段，其安全性和有效性尚未得到任何监管机构的评估。

About Sanofi

关于赛诺菲

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions..

我们是一家创新的全球医疗保健公司，由一个目标驱动：我们追求科学的奇迹以改善人们的生活。我们的团队遍布全球，致力于通过努力将不可能变为可能来改变医学实践。我们为全球数百万人提供可能改变生命的治疗选择和挽救生命的疫苗保护，同时将可持续性和社会责任置于我们抱负的核心。