NAARDEN, The Netherlands and MIAMI, July 08, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the completion of patient enrollment in the pivotal Phase 3 TANDEM clinical trial evaluating the fixed-dose combination (“FDC”) of obicetrapib plus ezetimibe in adult patients with Heterozygous Familial Hypercholesterolemia (“HeFH”) and/or Atherosclerotic Cardiovascular Disease (“ASCVD”) or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies..

荷兰纳亚登和迈阿密，2024年7月8日（环球通讯社）--新阿姆斯特丹制药公司（Nasdaq:NAMS或“新阿姆斯特丹”或“公司”），一家晚期临床生物制药公司，为低密度脂蛋白胆固醇（LDL-C）升高的心血管疾病（“CVD”）风险患者开发口服非他汀类药物，现有疗法对其疗效不佳或耐受性不佳，今天宣布完成关键的3期串联临床试验的患者登记，该试验评估了obicetrapib加依折麦布在成年杂合性家族性高胆固醇血症（“HE”）患者中的固定剂量组合（“FDC”）FH”）和/或动脉粥样硬化性心血管疾病（“ASCVD”）或ASCVD的多种危险因素，尽管采用了最大耐受性的脂质修饰疗法，但其LDL-C仍未得到充分控制。。

“Completing enrollment of the pivotal Phase 3 TANDEM trial marks an important step in our mission of advancing obicetrapib through late-stage clinical development and brings us closer to delivering a simple and convenient once-daily tablet to the millions of people suffering from dyslipidemia,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma.

新阿姆斯特丹制药首席执行官迈克尔·戴维森医学博士说：“完成关键的3期串联试验的注册，标志着我们通过晚期临床开发推进obicetrapib的使命迈出了重要的一步，使我们更接近于为数百万血脂异常患者提供一种简单方便的每日一次的片剂。”。

“With positive enrollment trends observed in four ongoing contemporaneous pivotal Phase 3 studies – BROOKLYN, BROADWAY, PREVAIL and TANDEM – we continue to be encouraged by physician and patient interest in our clinical trials, which we believe reflects growing awareness of our CETP inhibitor and its potential ability to address elevated LDL-C and improve health outcomes for millions of patients globally, if approved.

“在布鲁克林、百老汇、PREVAIL和TANDEM四项正在进行的同期关键性3期研究中观察到积极的入学趋势，我们继续受到医生和患者对我们临床试验的兴趣的鼓舞，我们认为这反映了人们对CETP抑制剂的认识不断提高，如果获得批准，它有可能解决LDL-C升高的问题，并改善全球数百万患者的健康状况。

We look forward to sharing topline data from the TANDEM study in the first quarter of 2025.”.

我们期待着在2025年第一季度分享串联研究的主要数据。”。

The double-blind, placebo-controlled Phase 3 TANDEM clinical trial enrolled 407 patients with HeFH and/or ASCVD or ASCVD risk equivalents, who have a baseline LDL-C of at least 70 mg/dL. The primary objective of the placebo-controlled, double-blind, four-arm, randomized TANDEM trial is to evaluate the effect of 10 mg obicetrapib and 10 mg ezetimibe FDC on the change in LDL-C levels from baseline, compared to both ezetimibe 10 mg and obicetrapib 10 mg monotherapy and to placebo.

这项双盲，安慰剂对照的3期串联临床试验招募了407名HeFH和/或ASCVD或ASCVD风险等效患者，他们的基线LDL-C至少为70 mg/dL。安慰剂对照，双盲，四臂随机串联试验的主要目的是评估10 mg obicetrapib和10 mg依折麦布FDC对基线LDL-C水平变化的影响，与依泽替米布10 mg和obicetrapib 10 mg单药治疗和安慰剂相比。

Secondary objectives include evaluating the effect of the FDC on lipoprotein(a) (“Lp(a)”), apolipoprotein B (“ApoB”) and non-high-density lipoprotein cholesterol (“non-HDL-C”). The trial will also evaluate the safety and tolerability profile of the FDC..

次要目标包括评估FDC对脂蛋白（a）（“Lp（a）”），载脂蛋白B（“ApoB”）和非高密度脂蛋白胆固醇（“非HDL-C”）的影响。该试验还将评估FDC的安全性和耐受性。。

“Cardiovascular disease is one of the most impactful global health issues, and while statins and ezetimibe have become standard therapies for patients with elevated cholesterol at high cardiovascular risk, a significant proportion of these patients still struggle to achieve target LDL-C levels,” said Ashish Sarraju, M.D., Cardiovascular Medicine, Cleveland Clinic.

。

“Based on clinical data generated to date, and a promising synergistic effect observed when combined with ezetimibe, obicetrapib has potential to play a critical role in the lipid-lowering and CVD treatment landscapes, if approved. I’m excited to partner with NewAmsterdam on the TANDEM trial and look forward to results early next year.”.

“根据迄今为止产生的临床数据，以及与依折麦布联合使用时观察到的有希望的协同作用，如果获得批准，obicetrapib有可能在降脂和心血管疾病治疗领域发挥关键作用。我很高兴与新阿姆斯特丹合作进行串联试验，并期待明年年初的结果。”。

About Obicetrapib

关于Obicetrapib

Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo.

Obicetrapib是一种新型口服低剂量CETP抑制剂，新阿姆斯特丹正在开发，以克服目前低密度脂蛋白降低治疗的局限性。在该公司的每个2期试验中，ROSE2，TULIP，ROSE和OCEAN评估obicetrapib作为单一疗法或联合疗法，该公司观察到统计学上显着的LDL降低以及类似于安慰剂的副作用。

The Company is conducting two Phase 3 pivotal trials, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering for CVD patients and TANDEM, to evaluate obicetrapib and ezetimibe as a fixed-dose combination.

公司正在进行两项三期关键性试验，一项是 BROADWAY 和 BROOKLYN 试验，以评估作为最大耐受性降脂疗法辅助疗法的 obicetrapib 单一疗法，为心血管疾病患者提供额外的降 LDL 治疗；另一项是 TANDEM 试验，以评估作为固定剂量组合疗法的 obicetrapib 和 ezetimibe。

The Company began enrolling patients in BROADWAY in January 2022, in BROOKLYN in July 2022, and in TANDEM in March 2024; completing enrollment of BROOKLYN in April 2023, BROADWAY in July 2023 and TANDEM in July 2024. The Company also commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization.

该公司于2022年1月在百老汇、2022年7月在布鲁克林以及2024年3月开始招募患者；2023年4月完成布鲁克林、2023年7月完成百老汇和2024年7月完成TANDEM的注册。该公司还在2022年3月开始了3期PREVAIL心血管结局试验，该试验旨在评估obicetrapib减少主要不良心血管事件发生的潜力，包括心血管死亡，非致命性心肌梗死，非致命性中风和非选择性冠状动脉血运重建。

NewAmsterdam completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients..

新阿姆斯特丹于2024年4月完成了PREVAIL的登记，并随机分配了9500多名患者。。

About NewAmsterdam

关于新阿姆斯特丹

NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy.

新阿姆斯特丹制药公司（Nasdaq:NAMS）是一家晚期生物制药公司，其使命是改善代谢疾病人群的患者护理，目前批准的治疗方法尚未充分或耐受性良好。我们寻求填补安全，耐受性良好和方便的低密度脂蛋白降低疗法的重大未满足需求。

In multiple phase 3 studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated..

在多个3期研究中，新阿姆斯特丹正在研究obicetrapib，一种口服，低剂量和每日一次的CETP抑制剂，单独或作为与依折麦布的固定剂量组合，作为LDL-C降低疗法，作为他汀类药物治疗的辅助手段，用于LDL-C升高的CVD风险患者，现有疗法对其不够有效或耐受性不佳。。