The AERIFY-1 phase 3 study evaluating itepekimab in former smokers with inadequately controlled chronic obstructive pulmonary disease (COPD) met the primary endpoint of a statistically significant reduction in moderate or severe acute exacerbations compared to placebo of 27% at week 52, a clinically meaningful benefit.

AERIFY-1 第三阶段研究评估了itepekimab在既往吸烟且控制不佳的慢性阻塞性肺疾病（COPD）患者中的效果，达到了主要终点，即与安慰剂相比，在第52周时中度或重度急性加重的统计学显著减少27%，具有临床意义。

The AERIFY-2 phase 3 study did not meet the same primary endpoint, although a benefit was seen earlier in the trial. .

AERIFY-2 第三阶段研究未达到相同的首要终点，尽管在试验早期曾观察到益处。

In the studies, patients were randomized to receive itepekimab every two weeks (AERIFY-1: n=375; AERIFY-2: n=326), every four weeks (AERIFY-1: n=377; AERIFY-2: n=303), or placebo (AERIFY-1: n=375; AERIFY-2: n=324), which was added to inhaled triple or double standard-of-care therapy. The primary endpoint analysis for AERIFY-1 and AERIFY-2 was the reduction in the annualized rate of acute moderate or severe COPD exacerbations with itepekimab treatment.

在研究中，患者被随机分配每两周接受itepekimab（AERIFY-1：n=375；AERIFY-2：n=326）、每四周一次（AERIFY-1：n=377；AERIFY-2：n=303），或安慰剂（AERIFY-1：n=375；AERIFY-2：n=324），这些均添加到吸入性三联或二联标准治疗中。AERIFY-1和AERIFY-2的主要终点分析是通过itepekimab治疗减少中度或重度COPD急性加重的年化率。

The table below summarizes the reductions in moderate or severe exacerbations (itepekimab compared to placebo) through weeks 24 and 52:

下表总结了通过第 24 周和第 52 周时，中度或重度急性加重的减少情况（伊替普单抗与安慰剂相比）：

AERIFY-1

AERIFY-1

AERIFY-2

AERIFY-2

Week 24

第24周

Week 52

第52周

Week 24

第24周

Week 52

第52周

Itepekimab every two weeks

每两周使用一次伊替普利单抗

30%

30%

27%

27%

a

a

18%

18%

2%

2%

Itepekimab every four weeks

每四周使用一次Itepekimab

34%

34%

21%

21%

a

a

21%

21%

12%

12%

a

a

Formal significance testing was only performed at 52 weeks in the Phase 3 trials, with significance achieved for both the every two-week arm and every four-week arm in AERIFY-1

在三期试验中，正式的显著性检验仅在第52周进行，在AERIFY-1中，每两周一次组和每四周一次组均达到了显著性。

The total number of exacerbations were lower than prospectively anticipated, decreasing the power of both trials. Enrollment largely occurred during the time of the global COVID pandemic, which could have contributed to the overall lower exacerbation rates.

急性加重的总次数低于预期，降低了两项试验的效力。入组主要发生在全球新冠疫情大流行期间，这可能促成了总体上较低的急性加重率。

Houman Ashrafian, MD, PhD

侯曼·阿什拉菲安，医学博士，哲学博士

Executive Vice President, Head of Research and Development at Sanofi

执行副总裁，赛诺菲研发部门负责人

“While we are encouraged by the results of AERIFY-1, the results of both studies merit further exploration to have a full understanding of the data and the role that IL33 plays in this complex disease. Certain people with COPD are in desperate need of new treatment options, especially those who continue to experience exacerbations despite being on maximal therapy, and we remain committed to discussing these data with regulatory agencies to evaluate our path forward.” .

“虽然我们对AERIFY-1的结果感到鼓舞，但这两项研究的结果值得进一步探索，以充分理解数据以及IL33在这种复杂疾病中的作用。某些COPD患者急需新的治疗选择，特别是那些即使在接受最大治疗后仍然经历病情加重的患者，我们依然致力于与监管机构讨论这些数据，以评估我们的前进路径。”

The safety profile of itepekimab was consistent across dosing regimens, and adverse events (AEs) were generally comparable between treatment and placebo groups. In AERIFY-1, the overall rates of AEs were 67% and 68% for itepekimab every two weeks and every four weeks, respectively, compared to 68% for placebo.

Itepekimab 的安全性在不同剂量方案中表现一致，治疗组和安慰剂组的不良事件 (AEs) 总体相当。在 AERIFY-1 研究中，每两周一次和每四周一次 itepekimab 的总体不良事件发生率分别为 67% 和 68%，而安慰剂组为 68%。

In AERIFY-2, the overall rates of AEs were 64% and 71% for itepekimab every two weeks and every four weeks, respectively, compared to 64% for placebo. In AERIFY-1, the rate of serious infections was 7% for each itepekimab arm, compared to 10% for placebo. In AERIFY-2, the rate of serious infections was 10% and 7% for itepekimab every two weeks and every four weeks, respectively, compared to 7% for placebo.

在AERIFY-2中，每两周使用itepekimab的总体不良事件（AE）发生率为64%，每四周使用itepekimab的发生率为71%，相比之下安慰剂组为64%。在AERIFY-1中，itepekimab各组严重感染的发生率为7%，而安慰剂组为10%。在AERIFY-2中，每两周使用itepekimab的严重感染发生率为10%，每四周使用itepekimab的发生率为7%，相比之下安慰剂组为7%。

AEs leading to death were 1% for each itepekimab arm compared to 2% for placebo in AERIFY-1, and 3% for each itepekimab arm compared to 2% for placebo in AERIFY-2. Anti-drug antibodies were rare and had no apparent impact on itepekimab drug levels..

在AERIFY-1试验中，itepekimab组导致死亡的不良事件（AEs）发生率为1%，而安慰剂组为2%；在AERIFY-2试验中，itepekimab组的发生率为3%，而安慰剂组为2%。抗药物抗体很少见，且对itepekimab的药物水平没有明显影响。

Sanofi and Regeneron are reviewing the data and will discuss with regulatory authorities to evaluate next steps.

赛诺菲和再生元正在审查数据，并将与监管机构讨论以评估下一步行动。

Detailed results from these studies will be presented at a future medical meeting. Itepekimab is currently being evaluated in other studies, including chronic rhinosinusitis with nasal polyps (CRSwNP), chronic rhinosinusitis without nasal polyps (CRSsNP), and bronchiectasis.

这些研究的详细结果将在未来的医学会议上公布。Itepekimab目前正在其他研究中进行评估，包括伴鼻息肉的慢性鼻窦炎 (CRSwNP)、不伴鼻息肉的慢性鼻窦炎 (CRSsNP) 和支气管扩张症。

George D. Yancopoulos, M.D., Ph.D.

乔治·D·扬科普洛斯，医学博士，哲学博士

Board co-Chair, President and Chief Scientific Officer at Regeneron

再生元公司的董事会联合主席、总裁兼首席科学官

“COPD is a particularly complex disease, and novel approaches are needed to address the multiple underlying biological disease driver. We are proud of our work in this challenging treatment landscape, bringing Dupixent – the first-ever biologic medicine for COPD – to certain patients who previously had very limited options remaining.

“COPD是一种特别复杂的疾病，需要新的方法来应对多种潜在的生物学疾病驱动因素。我们为在这一充满挑战的治疗领域所开展的工作感到自豪，将Dupixent——首款用于COPD的生物药物——带给那些之前选择非常有限的特定患者。”

We are encouraged by the initial results from AERIFY-1 and are carefully reviewing the results from both itepekimab trials to inform next steps. We remain committed to our broader itepekimab development program. The learnings will be invaluable as we continue to advance itepekimab in respiratory diseases with unmet need.” .

我们对AERIFY-1的初步结果感到鼓舞，并正在仔细审查两项依替匹单抗试验的结果，以指导下一步行动。我们仍然致力于更广泛的依替匹单抗开发计划。这些经验将为我们继续在未满足需求的呼吸系统疾病中推进依替匹单抗提供宝贵的参考。

The safety and efficacy of itepekimab are currently under clinical investigation and have not been fully evaluated by any regulatory authority.

itepekimab 的安全性和有效性目前正在临床研究中，尚未得到任何监管机构的全面评估。

About itepekimab

关于伊替培单抗

Itepekimab is a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL33), an initiator and amplifier of broad inflammation in COPD. IL33 is thought to be involved in different types of inflammation and is particularly elevated in the lungs of former smokers.

Itepekimab 是一种全人源单克隆抗体，能够结合并抑制白细胞介素-33（IL33），这是慢性阻塞性肺病（COPD）中广泛炎症的启动因子和放大因子。IL33 被认为参与了不同类型的炎症，并在既往吸烟者的肺部中显著升高。

Itepekimab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement and is currently in clinical development programs for CRSwNP (phase 3), non-cystic fibrosis bronchiectasis (phase 2), and CRSsNP (phase 2).

依替普单抗正在由赛诺菲和再生元根据全球合作协议共同开发，目前正处于针对慢性鼻窦炎伴鼻息肉（3期）、非囊性纤维化支气管扩张症（2期）和慢性鼻窦炎不伴鼻息肉（2期）的临床开发项目中。

About the AERIFY clinical study program

关于AERIFY临床研究计划

AERIFY-1 and AERIFY-2 phase 3 studies were randomized, Phase 3, double-blind, placebo-controlled studies that evaluated the efficacy and safety of itepekimab in 1,127 (AERIFY-1) and 953 (AERIFY-2) adults aged 40-85 years who were former smokers with moderate-to-severe COPD. Former smokers were defined as those who have not smoked for at least six months.

AERIFY-1和AERIFY-2的第三阶段研究是随机、双盲、安慰剂对照的三期临床试验，评估了伊替匹单抗在1,127名（AERIFY-1）和953名（AERIFY-2）40至85岁曾吸烟的中重度慢性阻塞性肺疾病（COPD）成人患者中的有效性和安全性。曾吸烟者定义为至少六个月内未吸烟的人。

Treatments were administered subcutaneously and added to double therapy (inhaled corticosteroid [ICS] plus long-acting beta2-agonist [LABA] or long-acting muscarinic antagonist [LAMA] plus LABA) or a maximal standard-of-care inhaled triple therapy (ICS, LABA and LAMA). .

治疗通过皮下注射方式进行，并加入双重疗法（吸入性糖皮质激素[ICS]加长效β2-激动剂[LABA]，或长效毒蕈碱拮抗剂[LAMA]加LABA），或最大标准护理的吸入三联疗法（ICS、LABA和LAMA）。

The primary endpoint for AERIFY-1 and AERIFY-2 was the annualized rate of acute moderate or severe COPD exacerbations. Moderate exacerbations were defined as those requiring systemic steroids and/or antibiotics. Severe exacerbations, also assessed separately as a pre-specified endpoint, were defined as those: requiring hospitalization; more than 24 hours of observation in an emergency department or urgent care facility; or resulting in death.

AERIFY-1 和 AERIFY-2 的主要终点是急性中度或重度 COPD 急性加重的年化率。中度加重定义为需要使用全身性类固醇和/或抗生素的加重。重度加重被单独作为一个预设终点进行评估，定义为以下情况：需要住院治疗；在急诊科或紧急护理机构观察超过 24 小时；或导致死亡。

The AERIFY program includes two additional ongoing trials: AERIFY-3, a Phase 2 mechanistic study assessing the impact of itepekimab on airway inflammation in patients with COPD, and AERIFY-4, a Phase 3 study assessing the long-term safety of itepekimab in patients with COPD.

AERIFY项目还包括两项正在进行的试验：AERIFY-3，这是一项2期机制研究，评估Itepekimab对慢性阻塞性肺病（COPD）患者气道炎症的影响；以及AERIFY-4，这是一项3期研究，评估Itepekimab在COPD患者中的长期安全性。

About Sanofi

关于赛诺菲

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating 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、以人工智能为助力的生物制药公司，致力于改善人们的生活并创造引人注目的增长。我们凭借对免疫系统的深刻理解，开发出能够治疗和保护全球数百万人的药物和疫苗，并通过创新的研发管线惠及更多人群。我们的团队秉持一个使命：追逐科学的奇迹以改善人们的生活；这激励我们推动进步，为员工及服务的社区带来积极影响，解决当今最紧迫的医疗、环境和社会挑战。

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

赛诺菲在 EURONEXT（欧洲证券交易所）上市，代码为 SAN；在 NASDAQ（纳斯达克）上市，代码为 SNY。

About Regeneron

关于再生元

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories.

再生元公司（纳斯达克代码：REGN）是一家领先的生物技术公司，为患有严重疾病的患者发明、开发和商业化改变生命的药物。公司由医生科学家创立并领导，我们独特的能力在于能够反复且持续地将科学转化为医学成果，目前已推出众多获批疗法及正在开发的候选产品，其中大部分都是在我们实验室内部自主研发的。

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases..

我们的药物和研发管线旨在帮助患有眼疾、过敏性和炎症性疾病、癌症、心血管和代谢疾病、神经性疾病、血液病、传染病和罕见病的患者。

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as

Regeneron利用我们的专有技术，如[具体技术]，推动科学发现的边界，加速药物开发。

which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center

这将产生优化的全人源抗体和新种类的双特异性抗体。我们正在通过来自Regeneron遗传学中心的数据驱动洞察力，塑造医学的下一个前沿。