CAMBRIDGE, Mass.--(BUSINESS WIRE)--Anthos Therapeutics, Inc., a clinical stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences, announced today that the AZALEA-TIMI 71 Phase 2 study in 1,287 patients with atrial fibrillation at moderate-to-high risk of stroke, met its primary endpoint.

马萨诸塞州剑桥市-由Blackstone Life Sciences创立的开发心血管疾病创新疗法的临床阶段公司Anthos Therapeutics，Inc。今天宣布，对1287名心房患者进行AZALEA-TIMI 71期2期研究。中度至高度中风风险的纤颤，达到其主要终点。

The study has been stopped early by the Data Monitoring Committee due to an overwhelming reduction in the composite of major and clinically relevant non-major bleeding in patients taking abelacimab compared with patients taking rivaroxaban, a leading standard-of-care DOAC. In addition, abelacimab is the first and only Factor XI inhibitor to demonstrate an unprecedented reduction in major bleeding compared to a DOAC, which is the most serious type of bleeding.

数据监测委员会早期停止了这项研究，因为与服用利伐沙班（一种主要的护理标准DOAC）的患者相比，服用abelacimab的患者的主要和临床相关的非主要出血复合物大幅减少。此外，与DOAC（最严重的出血类型）相比，abelacimab是第一个也是唯一一个显示出大出血前所未有的减少的XI因子抑制剂。

Full results of AZALEA-TIMI 71 will be presented at an upcoming scientific congress..

AZALEA-TIMI 71的全部成果将在即将召开的科学大会上发表。。

“The AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to the standard-of-care anticoagulant. With a median of 21 months of follow-up, spanning more than 2,000 patient-years, AZALEA-TIMI 71 represents a landmark study confirming the promise of Factor XI inhibition as causing substantially less bleeding than a current standard-of-care,” said Marc S.

“AZALEA-TIMI 71研究是对XI因子抑制剂进行的最大和最长的头对头研究，旨在提供与标准护理抗凝剂相比出血显着减少的明确证据。中位数为21个月随访超过2000患者年，AZALEA-TIMI 71代表了一项具有里程碑意义的研究，证实了因子XI抑制的前景马克·s说，这比目前的护理标准要少得多。

Sabatine, MD, MPH, the Lewis Dexter, MD, Distinguished Chair in Cardiovascular Medicine, Brigham and Women’s Hospital; Professor, Harvard Medical School; and Chairman of the Thrombolysis in Myocardial Infarction (TIMI) Study Group..

Sabatine，医学博士，公共卫生硕士，Lewis Dexter，医学博士，布莱根妇女医院心血管医学杰出主席；哈佛医学院教授；心肌梗死溶栓治疗（TIMI）研究组主席。。

Abelacimab is a novel, highly selective, fully human monoclonal antibody with dual inhibitory activity against Factor XI and its active form, Factor XIa. Abelacimab 150 mg maintains ~98% inhibition over the dosing interval, recapitulating the benign bleeding profile of patients with genetic Factor XI deficiency.

Abelacimab是一种新型，高选择性，完全人源化的单克隆抗体，对因子XI及其活性形式因子XIa具有双重抑制活性。Abelacimab 150 mg在给药间隔内维持约98%的抑制，概括了遗传因子XI缺乏症患者的良性出血情况。

Prior to AZALEA-TIMI 71, abelacimab achieved a ~80% reduction in venous thromboembolism (VTE) versus a standard-of-care comparator in a gold standard proof-of-concept efficacy study that was published in the New England Journal of Medicine.1.

在AZALEA-TIMI 71之前，abelacimab在新英格兰医学杂志上发表的金标准概念验证疗效研究中，与标准治疗对照组相比，静脉血栓栓塞（VTE）降低了约80%。

“Given AZALEA-TIMI 71’s overwhelming reduction in bleeding, together with an 80% reduction in thrombosis demonstrated in our earlier VTE study,1 abelacimab embodies its promise as a hemostasis-sparing anticoagulant and represents a paradigm shift in the prevention of stroke and other thrombotic conditions,” said Dan Bloomfield, MD, Chief Medical Officer of Anthos Therapeutics.

“鉴于AZALEA-TIMI 71的出血量大幅减少，以及我们早期的VTE研究显示血栓形成减少80%，abelacimab体现了其作为止血抗凝剂的前景，并且代表了预防中风和其他血栓形成病症的范式转变，”Anthos Therapeutics首席医疗官Dan Bloomfield博士说。

“If approved, more patients with atrial fibrillation could be treated effectively and safely, with a much lower risk of bleeding with abelacimab as compared to a DOAC.”.

“如果获得批准，更多的房颤患者可以得到有效和安全的治疗，与DOAC相比，abelacimab的出血风险要低得多。”。

The Center for Disease Control and Prevention (CDC) estimates that 12.1 million people in the United States will have atrial fibrillation by 2030.2 Unfortunately, 40% to 60% of patients with atrial fibrillation are not prescribed anticoagulants today. This underuse of anticoagulants for stroke prevention has been cited as one of the greatest public health issues facing cardiovascular patients.3 In a physician survey, the foremost barrier to patients taking oral anticoagulants was bleed related.4.

疾病控制和预防中心（CDC）估计，到2030年，美国将有1210万人患有心房颤动.2不幸的是，40%至60%的心房颤动患者今天没有使用抗凝剂。这种用于预防卒中的抗凝剂使用不足被认为是心血管患者面临的最大公共卫生问题之一.3在医生调查中，服用口服抗凝剂的患者最重要的障碍是出血相关的。

“Abelacimab has the potential to provide a game-changing treatment option for all those patients who live with the daily fear of bleeding while taking current anticoagulants. We can now imagine a future where these patients are able to resume and enjoy activities that they are currently being forced to give up due to concerns associated with bleeding,” said Leslie Lake, President of the National Blood Clot Alliance.

Leslie Lake说：“Abelacimab有可能为所有那些在服用当前抗凝剂时每天都担心出血的患者提供改变游戏规则的治疗选择，我们现在可以想象一个未来，这些患者能够恢复并享受他们目前正在进行的活动。由于与出血有关的担忧而被迫放弃，全国血液凝块联盟主席。

“We are thrilled that AZALEA-TIMI 71 has demonstrated such a positive outcome and excited about the promise that it offers to patients.”.

“我们很高兴AZALEA-TIMI 71已经证明了这样一个积极的结果，并对它为患者提供的承诺感到兴奋。”。

Anthos Therapeutics has initiated an extension study to enable patients to transition from rivaroxaban to abelacimab to benefit from the improved bleeding profile. Further, a Fast-Track Designation for abelacimab was previously granted by the U.S. Food and Drug Administration for the prevention of stroke and systemic embolism in patients with atrial fibrillation..

Anthos Therapeutics已经启动了一项扩展研究，使患者能够从利伐沙班过渡到abelacimab，从而从改善的出血情况中受益。此外，美国食品和药物管理局先前批准了abelacimab的快速通道名称，用于预防心房颤动患者的中风和全身性栓塞。。

About Abelacimab

关于Abelacimab

Abelacimab is a novel, highly selective, fully human monoclonal antibody that locks Factor XI in the inactive state, resulting in dual inhibitory activity against both Factor XI and its activated form, Factor XIa. By uncoupling thrombosis from hemostasis, a dual-activity Factor XI inhibitor may provide a path forward for those patients who would benefit from the protection that anticoagulants can provide..

Abelacimab是一种新型，高选择性，完全人源化的单克隆抗体，可将因子XI锁定在非活性状态，从而对因子XI及其活化形式因子XIa产生双重抑制活性。通过使血栓形成与止血脱钩，双重活性因子XI抑制剂可以为那些受益于抗凝剂可以提供的保护的患者提供前进的道路。。

In a PK / PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days.5 In a Phase 2 study published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.1 Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.6.

在PK/PD研究中，静脉注射abelacimab可在治疗开始后1小时内显着抑制因子XI，并在30天内保持接近最大抑制.5在新英格兰医学杂志上发表的2期研究中2021年，膝关节手术后单次静脉注射abelacimab可使静脉血栓栓塞发生率降低80%，与依诺肝素相比，术后10天测量.1因子XI抑制为预防和治疗动脉和静脉血栓栓塞事件提供了止血保留抗凝的前景。

Abelacimab is an investigational agent and is not approved for any indication in any country.

Abelacimab是一种研究药物，未被批准用于任何国家的任何适应症。

About the AZALEA-TIMI 71 Phase 2 Study

关于AZALEA-TIMI 71第二阶段研究

The AZALEA-TIMI 71 study is an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study with a primary endpoint that evaluates the effect of two blinded doses of abelacimab relative to open-label rivaroxaban in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke.

AZALEA-TIMI 71研究是一项事件驱动，随机，主动控制，盲法终点，平行组研究，主要终点评估两种盲法剂量的abelacimab相对于开放标签利伐沙班对房颤患者的影响（AF）中风风险中至高风险。

The primary endpoint of the AZALEA-TIMI 71 study is the composite of the rate of major or clinically relevant non-major bleeding events. A secondary endpoint is major bleeding on its own. Patients were randomized 1:1:1 and administered subcutaneous (SC) abelacimab 150 mg once-monthly, abelacimab 90 mg once-monthly or rivaroxaban 20 mg daily.

AZALEA-TIMI 71研究的主要终点是主要或临床相关的非主要出血事件发生率的综合。次要终点是自身的大出血。患者以1:1:1随机分组，每月一次皮下（SC）abelacimab 150 mg，每月一次abelacimab 90 mg或利伐沙班20 mg。

This event-driven study completed enrollment in December 2021, with 1,287 patients across 95 global study sites including the U.S. and Canada, Europe and Asia..

这项由事件驱动的研究于2021年12月完成招募，在95个全球研究地点（包括美国和加拿大，欧洲和亚洲）共有1287名患者。。

About the LILAC-TIMI 76 Phase 3 Study

关于LILAC-TIMI 76第三阶段研究

The LILAC-TIMI 76 study is an event-driven, randomized, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism in patients with atrial fibrillation (AF) who have been deemed to be unsuitable for currently available anticoagulation therapy.

LILAC-TIMI 76研究是一项事件驱动，随机，安慰剂对照，双盲，平行组研究，旨在评估abelacimab相对于安慰剂对心房颤动患者缺血性卒中或全身栓塞发生率的有效性和安全性（AF）被认为不适合目前可用的抗凝治疗。

Patients in the study will be randomized to receive abelacimab 150 mg SC or matching placebo once monthly. The study is targeting to enroll approximately 1,900 patients from more than 400 sites in North America, Europe, Latin America, the Middle East and Asia..

研究中的患者将随机接受abelacimab 150 mg SC或匹配的安慰剂每月一次。该研究旨在招募来自北美，欧洲，拉丁美洲，中东和亚洲400多个地点的约1900名患者。。

About Anthos Therapeutics

关于Anthos疗法

Anthos Therapeutics was launched by Blackstone Life Sciences in 2019 and obtained from Novartis Pharma the exclusive global rights to develop, manufacture, and commercialize abelacimab. Anthos Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of genetically and pharmacologically validated innovative therapies to advance care for high-risk cardiovascular patients.

Anthos Therapeutics由Blackstone Life Sciences于2019年推出，并从诺华制药获得开发，制造和商业化abelacimab的独家全球权利。Anthos Therapeutics是一家临床阶段的生物制药公司，专注于基因和药理学验证的创新疗法的开发和商业化，以推进对高风险心血管患者的护理。

For more information, visit the company’s website and follow on Twitter and LinkedIn..

欲了解更多信息，请访问公司的网站，并关注Twitter和LinkedIn。。

Forward-Looking Statements

前瞻性声明

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the initiation, and timing, of future clinical trials and its research and development.

本新闻稿包含1995年“私人证券诉讼改革法”含义内的“前瞻性声明”，涉及未来临床试验及其研究与开发的启动，时间安排等重大风险和不确定性。

All statements, other than statements of historical facts, contained in this press release, including statements regarding the company’s strategy, future operations, future financial position, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “become,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

本新闻稿中包含的除历史事实陈述外的所有陈述，包括有关公司战略，未来运营，未来财务状况，前景，管理计划和目标的陈述，均为前瞻性陈述。“预期”，“成为”，“相信”，“继续”，“可以”，“估计”，“期望”，“打算”，“可以”，“计划”，“潜力”，“预测”，“项目”，“应该”，“目标”，“将会”等词语旨在确定前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。

Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof.

任何前瞻性陈述均基于管理层对未来事件的当前预期，并受到许多风险和不确定性的影响，这些风险和不确定性可能导致实际结果与此类前瞻性陈述中提出或暗示的实际结果产生重大不利影响。此外，本新闻稿中包含的前瞻性声明代表本公司自本协议签署之日起的观点，不应视为本公司自本协议签署之日起任何日期的观点。

The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so..

公司预计随后的事件和发展将导致公司的观点发生变化。但是，虽然公司可能会选择在未来某个时候更新这些前瞻性声明，但公司明确拒绝任何义务这样做。。

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