– Novo Nordisk today presented results from the phase 3b FRONTIER5 trial showing that a direct switch to investigational Mim8 (denecimig) prophylaxis from emicizumab treatment, without a washout period or Mim8 loading dose, was well-tolerated with no safety concerns in adults and adolescents living with haemophilia A, with or without inhibitors.

– 诺和诺德公司今天公布了3b期FRONTIER5试验的结果，显示对于患有A型血友病（无论是否带有抑制因子）的成人和青少年患者，直接从emicizumab治疗转换为试验性药物Mim8（denecimig）预防治疗，无需洗脱期或Mim8负荷剂量，且耐受性良好，无安全问题。

. Additionally, a FRONTIER5 Patient-Reported Outcomes (PROs) assessment found the Mim8 pen-injector easy to use, with an overall strong user preference for the pen-injector compared to the previous emicizumab injection system

此外，FRONTIER5 患者报告结果（PROs）评估发现，Mim8 笔式注射器易于使用，与之前的艾米珠单抗注射系统相比，用户普遍更偏好该笔式注射器。

. The results were presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C.

。该结果在华盛顿特区举行的国际血栓与止血学会（ISTH）大会上公布。

In the study, the first Mim8 maintenance dose was administered on the next planned emicizumab dosing day. Patients were given the option of switching to once-monthly, once every two weeks or once-weekly dosing frequencies of Mim8, regardless of their prior dosing frequency

在研究中，第一个Mim8维持剂量是在下一个计划的艾米珠单抗给药日给予的。患者可以选择转换为每月一次、每两周一次或每周一次的Mim8给药频率，无论他们之前的给药频率如何。

. Steady-state Mim8 concentration was achieved by Week 16, and emicizumab elimination was completed by Week 26

到第16周达到了稳态的Mim8浓度，并且到第26周emicizumab的清除已完成。

. Switching to Mim8 led to a sustained increase in thrombin peak levels without an exaggerated thrombin response

切换到Mim8导致凝血酶峰值水平持续增加，而没有出现过度的凝血酶反应。

“Continuous prophylactic coverage is critical to avoiding breakthrough bleeds in people living with haemophilia; with new non-factor therapeutic options, many people could have hesitations about switching treatment options. These data demonstrate that switching to Mim8 from emicizumab can be done without requiring a washout period,” said Allison P.

“持续的预防性治疗对于避免血友病患者出现突破性出血至关重要；随着新的非因子治疗选择的出现，许多人可能会对更换治疗方案犹豫不决。这些数据表明，从艾米珠单抗转换到Mim8时无需进行洗脱期，”Allison P.说道。

Wheeler, MD, Washington Center for Bleeding Disorders, Seattle, WA. “This is critical in ensuring that individuals maintain continuous protection against bleeding events as we seek to help address the ongoing needs of people living with this complex disease.” .

惠勒，医学博士，华盛顿出血疾病中心，西雅图，华盛顿州。“这一点至关重要，因为我们在努力满足这种复杂疾病的患者不断变化的需求时，确保个人持续获得针对出血事件的保护。”

The open-label phase 3b FRONTIER5 study consisted of 61 adults and adolescents, aged 12 years and older, with haemophilia A. Mim8 was well-tolerated with no safety concerns. No thromboembolic events, hypersensitivity reactions, or treatment-emergent adverse events (TEAEs) leading to discontinuation were observed, and there was no clinical evidence of neutralising anti-Mim8 antibodies.

开放标签的 3b 期 FRONTIER5 研究包括 61 名 12 岁及以上的成人和青少年血友病 A 患者。Mim8 耐受性良好，无安全隐患。未观察到血栓栓塞事件、超敏反应或导致停药的治疗中出现的不良事件 (TEAE)，且没有临床证据表明存在中和抗 Mim8 抗体。

The PROs data from FRONTIER5 indicated a strong overall preference for the Mim8 pen-injector, with 97% (n=57/59) of patients reporting a “very strong” or “fairly strong” preference in comparison to their previous emicizumab injection system

FRONTIER5的患者报告结果数据显示，患者对Mim8笔式注射器表现出强烈的整体偏好，97%（n=57/59）的患者报告称，与之前的艾米珠单抗注射系统相比，他们有“非常强烈”或“相当强烈”的偏好。

. Of the participants who completed the Haemophilia Device Handling and Preference Assessment (HDHPA) questionnaire at week 26, 98% (n=58/59) found the Mim8 pen-injector “very easy” or “easy” to use, and 95% (n=56/59) found it “much easier” or “easier” compared with their previous administration method.

在第26周完成血友病设备操作和偏好评估（HDHPA）问卷的参与者中，98%（n=58/59）认为Mim8笔式注射器“非常容易”或“容易”使用，95%（n=56/59）认为与他们之前的给药方法相比，“容易得多”或“更容易”。

All participants (100%) were “extremely confident” or “very confident” in using the pen-injector correctly, and most participants (83%; n=49/59) found it “very easy” to inject the dose.

所有参与者（100%）在正确使用笔式注射器方面表示“非常有信心”或“很有信心”，并且大多数参与者（83%；n=49/59）认为注射剂量“非常容易”。

“The FRONTIER5 safety and patient-reported outcomes data support Mim8 as a potential future treatment option for people living with haemophilia A and demonstrate our continued commitment to developing innovative treatment options for this community”, said Stephanie Seremetis, chief medical officer and CVP for Haemophilia at Novo Nordisk.

“FRONTIER5 的安全性和患者报告的结果数据支持 Mim8 作为未来血友病 A 患者潜在的治疗选择，并彰显了我们持续致力于为这一群体开发创新治疗方案的承诺，”诺和诺德血友病首席医学官兼副总裁 Stephanie Seremetis 表示。

“These results give valuable insights into haemophilia A management, highlight the feasibility of directly switching to Mim8 from emicizumab, and reveal a strong patient preference for the Mim8 pen-injector device.”.

“这些结果为A型血友病的管理提供了宝贵的见解，突出了直接从艾米珠单抗转换为Mim8的可行性，并揭示了患者对Mim8笔式注射器设备的强烈偏好。”

Novo Nordisk expects to submit Mim8 for regulatory review during 2025. Data from the ongoing phase 3 FRONTIER programme will be disclosed at upcoming congresses and in publications in 2025 and 2026.

诺和诺德预计将在2025年提交Mim8的监管审查。正在进行的3期FRONTIER项目的数据将在2025年和2026年的大会上披露，并在出版物中发布。

About haemophilia

关于血友病

Haemophilia is a rare inherited bleeding disorder that impairs the body’s ability to make blood clots, a process needed to stop bleeding

血友病是一种罕见的遗传性出血障碍，它削弱了身体形成血凝块的能力，而这是停止出血所需要的。

. It is estimated to affect approximately 1,125,000 people worldwide

据估计，全球约有1,125,000人受到影响

. There are different types of haemophilia, which are characterised by the type of clotting factor protein that is defective or missing

。血友病有不同的类型，其特征在于缺陷或缺失的凝血因子蛋白的类型。

. Haemophilia A is caused by a missing or defective clotting Factor VIII (FVIII), and haemophilia B is caused by a missing or defective clotting Factor IX

血友病A是由于缺失或有缺陷的凝血因子VIII（FVIII）引起的，而血友病B是由于缺失或有缺陷的凝血因子IX引起的。

. Inhibitors are an immune system response to the clotting factors in replacement therapy. Currently, it is estimated that up to 30% of people living with severe haemophilia A develop inhibitors

抑制剂是免疫系统对替代疗法中凝血因子的反应。据目前估计，多达30%的重度A型血友病患者会产生抑制剂。

that can cause replacement therapies to stop working.

可能导致替代疗法停止发挥作用。

About Mim8

关于Mim8

Mim8 is an investigational FVIIIa mimetic bispecific antibody optimised with the aim to deliver improved potency and sustained efficacy across flexible dosing intervals up to once-monthly prophylaxis for people living with haemophilia A, with or without inhibitors

Mim8是一种研究性FVIIIa模拟双特异性抗体，经过优化，旨在为血友病A患者（无论是否携带抑制物）提供增强的效力和持续的疗效，灵活给药间隔最长可达每月一次的预防治疗。

. Administered under the skin, Mim8 bridges Factor IXa and Factor X. This action replaces FVIII function, which helps restore the body’s thrombin generation capacity into the normal range, helping blood to clot

Mim8 通过皮下注射给药，连接凝血因子 IXa 和凝血因子 X。这种作用取代了 FVIII 的功能，有助于恢复体内凝血酶生成能力至正常范围，从而帮助血液凝固。

. The use of Mim8 in people living with haemophilia A is investigational and not approved by regulatory authorities or available anywhere in the world.

Mim8在血友病A患者中的使用是研究性的，尚未获得监管机构的批准，也未在全球任何地方上市。

About the FRONTIER5 trial

关于FRONTIER5试验

FRONTIER5 is a single-arm, open-label, 26-week, phase 3b trial evaluating the safety of switching from previous emicizumab prophylaxis treatment directly to Mim8 prophylaxis treatment using the Mim8 pen-injector in adults and adolescents with haemophilia A, with or without inhibitors

FRONTIER5 是一项单臂、开放标签、为期26周的3b期试验，评估先前接受艾米珠单抗预防治疗的成人和青少年血友病A患者（无论是否带有抑制剂）直接转换为使用Mim8注射笔进行Mim8预防治疗的安全性。

The FRONTIER clinical programme investigates Mim8 as a prophylaxis treatment for people with haemophilia A, with or without inhibitors. This programme includes FRONTIER1, FRONTIER2, FRONTIER3, FRONTIER4 and FRONTIER5

FRONTIER临床项目研究Mim8作为甲型血友病患者（无论是否具有抑制剂）的预防治疗。该项目包括FRONTIER1、FRONTIER2、FRONTIER3、FRONTIER4和FRONTIER5。

About Novo Nordisk

关于诺和诺德

Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease.

诺和诺德是一家全球领先的医疗保健公司，成立于1923年，总部位于丹麦。我们的宗旨是依托在糖尿病领域的深厚积淀，推动变革以战胜严重的慢性疾病。我们通过开创科学突破、扩大药品获取渠道以及努力预防并最终治愈疾病来实现这一目标。