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NewAmsterdam Pharma to Present New Clinical and Preclinical Data Highlighting Obicetrapib's Impact on Key Risk Factors for Cardiovascular Disease at Upcoming Medical Meetings

NewAmsterdam Pharma to Present New Clinical and Preclinical Data Highlighting Obicetrapib's Impact on Key Risk Factors for Cardiovascular Disease at Upcoming Medical Meetings

新阿姆斯特丹制药公司将在即将举行的医学会议上发布新的临床和临床前数据,重点介绍Obicetrapib对心血管疾病关键危险因素的影响
GlobeNewswire ·  05/21 08:00

-- Presentations include new data from OCEAN, ROSE, and ROSE2 Phase 2 clinical trials, demonstrating obicetrapib's impact on key lipid and lipoprotein biomarkers --

— 演讲包括来自 OCEAN、ROSE 和 ROSE2 2 期临床试验的新数据,表明了 obicetrapib 对关键脂质和脂蛋白生物标志物的影响 —

-- On track to report topline data from Phase 3 BROOKLYN trial in HeFH in 3Q 2024 and Phase 3 BROADWAY trial in ASCVD in 4Q 2024 --

— 有望在2024年第三季度报告HeFH的布鲁克林三期试验和2024年第四季度ASCVD的BROADWAY三期试验的主要数据——

NAARDEN, the Netherlands and MIAMI, May 21, 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 that it will present new clinical and preclinical data highlighting the potential for obicetrapib as a novel, oral, low-dose therapy for hypercholesterolemia, at the European Atherosclerosis Society (EAS) 92nd Congress and the National Lipid Association (NLA) 2024 Scientific Sessions, taking place on May 26 – 29 in Lyon, France and May 30 – June 2 in Las Vegas, Nevada, respectively.

荷兰纳尔登和迈阿密,2024年5月21日(GLOBE NEWSWIRE)——新阿姆斯特丹制药公司(纳斯达克股票代码:NAMS 或 “新阿姆斯特丹” 或 “公司”)是一家后期临床生物制药公司,为有心血管疾病(“CVD”)风险的低密度脂蛋白胆固醇(“LDL-C”)患者开发口服非他汀类药物,适用于低密度脂蛋白胆固醇(“LDL-C”)风险患者疗法不够有效或耐受性不佳,今天宣布将提供新的临床和临床前数据,强调obicetrapib作为一种新型、口服、低浓度的潜力欧洲动脉粥样硬化协会 (EAS) 92 的高胆固醇血症剂量疗法 国会和全国脂质协会(NLA)2024年科学会议,分别于5月26日至29日在法国里昂和5月30日至6月2日在内华达州拉斯维加斯举行。

Presentation details are as follows:

演示详情如下:

EAS 92nd Congress, Lyon, France, May 26-29, 2024

是 92 国会,法国里昂,2024 年 5 月 26 日至 29 日

Title: Obicetrapib Treatment Increases Pre-Beta1 HDL and Lipophilic Antioxidants in the OCEAN and ROSE2 Studies
Session Name: 0390 - SaaG Session: New tricks of HDL
Oral Presentation Session Date and Time: Monday, May 27, 2024, 2:42 PM- 2:49 PM CET (8:42 AM-8:49 AM ET)
Location: Station 7

标题:Obicetrapib 治疗可增加 OCEAN 和 ROSE2 研究中的 Beta1 前高密度脂蛋白和亲脂性抗氧化剂
会话名称:0390-SaAg 会话:HDL 的新技巧
口头演讲日期和时间:欧洲中部时间 2024 年 5 月 27 日星期一下午 2:42 至下午 2:49(美国东部时间上午 8:42 至上午 8:49)
地点:7 号站

Title: Obicetrapib Demonstrates Significant Reductions of Lp(a) on Top of High-Intensity Statins
Session Name: 0601 - SaaG Session: Late-breaking lipids
Oral Presentation Session Date and Time: Tuesday, May 28, 2024, 2:12 PM- 2:19 PM CET (8:12 AM-8:19 AM ET)
Location: Station 8

标题:除了高强度他汀类药物外,Obicetrapib还显示出Lp(a)的显著降低
会话名称:0601-SaAg 会话:最新发现的脂质
口头演讲日期和时间:欧洲中部时间 2024 年 5 月 28 日星期二下午 2:12 至下午 2:19(美国东部时间上午 8:12 至上午 8:19)
地点:8 号站

Title: Obicetrapib Alone and in Combination with Ezetimibe Reduces Non-HDL-Cholesterol by Enhanced LDL-Receptor-Mediated VLDL Clearance and Increased Net Fecal Sterol Excretion in APOE*3-Leiden.CETP Mice
Session Name: 0660- SaaG Session: Breaking updates in lipid-lowering treatments
Oral Presentation Session Date and Time: Tuesday, May 28, 2024, 3:17-3:24 CET (9:17 AM-9:24 AM ET)
Location: Station 3

标题:单独使用Obicetrapib以及与依泽替米贝联合使用可通过增强低密度脂蛋白受体介导的VLDL清除率和增加Apoe*3-Leiden.CETP小鼠的净粪便固醇排泄来降低非高密度脂蛋白胆固醇
会议名称:0660-SaAg 会议:降脂治疗的最新进展
口头演讲日期和时间:欧洲中部时间 2024 年 5 月 28 日星期二 3:17-3:24(美国东部时间上午 9:17 至上午 9:24)
地点:3 号站

Title: Obicetrapib Alone and in Combination with Ezetimibe Reduces Atherosclerotic Lesion Size and Severity in APOE*3-Leiden.CETP Mice
Session Name: 0660- SaaG Session: Breaking updates in lipid-lowering treatments
Oral Presentation Session Date and Time: Tuesday, May 28, 2024, 3:24-3:31 CET (9:24 AM-9:31 AM ET)
Location: Station 3

标题:单独使用Obicetrapib并与依泽替米贝联合使用可减轻Apoe*3-Leiden.cetp小鼠的动脉粥样硬化病变大小和严重程度
会议名称:0660-SaAg 会议:降脂治疗的最新进展
口头演讲日期和时间:欧洲中部时间 2024 年 5 月 28 日星期二 3:24-3:31(美国东部时间上午 9:24 至上午 9:31)
地点:3 号站

Title: Obicetrapib does not Accumulate in Adipose Tissue: Results from Studies in Man and Non-Human Primates
Flatboard Presentation Date: Monday, May 27 and Tuesday, May 28, 2024

标题:Obicetrapib 不会在脂肪组织中积累:对人类和非人类灵长类动物的研究结果
平板展示日期:2024 年 5 月 27 日星期一和 5 月 28 日星期二

NLA 2024 Scientific Sessions, Las Vegas, Nevada, May 30-June 2, 2024

NLA 2024 科学会议,内华达州拉斯维加斯,2024 年 5 月 30 日至 6 月 2 日

Title: Obicetrapib Demonstrates Significant Reductions Of Lp(a) On Top Of High-intensity Statins
Abstract/Poster #: 128
Date and Time: Friday, May 31, 2024, 2:30 PM- 2:55 PM PT (5:30 PM-5:55 PM ET)
Location: Poster Hall Monitor # 30

标题:除了高强度他汀类药物外,Obicetrapib还显示出Lp(a)的显著降低
摘要/海报编号:128
日期和时间:太平洋时间 2024 年 5 月 31 日星期五下午 2:30 至下午 2:55(美国东部时间下午 5:30 至下午 5:55)
地点:海报大厅监视器 #30

Title: Synergistic Effect of Obicetrapib and Ezetimibe on Circulating LDL Particles
Abstract/Poster #: 138
Date and Time: Friday, May 31, 2024, 2:30 PM- 2:55 PM PT (5:30 PM-5:55 PM ET)
Location: Poster Hall Monitor # 22

标题:Obicetrapib和依泽替米贝对循环低密度脂蛋白颗粒的协同作用
摘要/海报编号:138
日期和时间:太平洋时间 2024 年 5 月 31 日星期五下午 2:30 至下午 2:55(美国东部时间下午 5:30 至下午 5:55)
地点:22号海报大厅监视器

Title: Obicetrapib Does Not Accumulate in Adipose Tissue: Results from Studies in Man and Non-human Primates Abstract/Poster #: 127
Date and Time: Friday, May 31, 2024, 2:30 PM- 2:55 PM PT (5:30 PM-5:55 PM ET)
Location: Poster Hall Monitor # 18

标题:Obicetrapib 不会在脂肪组织中积累:对人类和非人类灵长类动物的研究结果摘要/海报编号:127
日期和时间:太平洋时间 2024 年 5 月 31 日星期五下午 2:30 至下午 2:55(美国东部时间下午 5:30 至下午 5:55)
地点:海报大厅监视器 #18

Title: Obicetrapib Treatment Increases Pre-Beta1 HDL and Lipophilic Antioxidants in the OCEAN and ROSE2 Studies
Abstract/Poster #: 140
Date and Time: Friday, May 31, 2024, 2:30 PM- 2:55 PM PT (5:30 PM-5:55 PM ET)
Location: Poster Hall Monitor # 15

标题:Obicetrapib 治疗可增加 OCEAN 和 ROSE2 研究中的 Beta1 前高密度脂蛋白和亲脂性抗氧化剂
摘要/海报编号:140
日期和时间:太平洋时间 2024 年 5 月 31 日星期五下午 2:30 至下午 2:55(美国东部时间下午 5:30 至下午 5:55)
地点:海报大厅监视器 #15

Title: Assessment of Unmet Clinical Needs and Healthcare Resource Use Among Statin-Treated Patients with or at Risk of Developing ASCVD
Abstract/Poster #: 139
Date and Time: Friday, May 31, 2024, 2:30 PM- 2:55 PM PT (5:30 PM-5:55 PM ET)
Location: Poster Hall Monitor # 12

标题:评估他汀类药物治疗的患有或有患ASCVD风险的患者中未满足的临床需求和医疗资源使用情况
摘要/海报编号:139
日期和时间:太平洋时间 2024 年 5 月 31 日星期五下午 2:30 至下午 2:55(美国东部时间下午 5:30 至下午 5:55)
地点:海报大厅监视器 #12

Presentation Title: Obicetrapib Alone and with Ezetimibe Reduces Non-HDL-C by Enhanced LDL-Receptor-Mediated VLDL Clearance and Increased Net Fecal Sterol Excretion
Abstract/Poster #: 141
Oral Presentation Session: Session V
Date and Time: Saturday, June 1, 2024, 11:05 AM- 11:55 AM PT (2:05-2:55 PM ET)

演讲题目:单独使用Obicetrapib和依泽替米贝通过增强低密度脂蛋白受体介导的VLDL清除率和增加粪便固醇净排泄量来降低非高密度脂蛋白C
摘要/海报编号:141
口头陈述会议:第五场会议
日期和时间:太平洋时间 2024 年 6 月 1 日星期六上午 11:05 至上午 11:55(美国东部时间下午 2:05-2:55)

About 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. 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. 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 and BROADWAY in July 2023. 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. NewAmsterdam completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients.

关于 Obicetrapib
Obicetrapib是一种新型的口服低剂量CETP抑制剂,新阿姆斯特丹正在开发该抑制剂,旨在克服当前降低低密度脂蛋白疗法的局限性。在该公司评估奥比曲拉匹为单一疗法或联合疗法的每项2期试验(ROSE2、TULIP、ROSE和OCEAN)中,该公司观察到具有统计学意义的低密度脂蛋白降低,副作用与安慰剂类似。该公司正在进行两项三期关键试验,即百老汇和布鲁克林,评估奥比曲匹作为一种单一疗法,可用作最大耐受性降脂疗法的辅助手段,为心血管疾病患者提供额外的低密度脂蛋白降低,并评估奥比曲匹和依泽替米贝作为固定剂量组合的药物。该公司于2022年1月开始在百老汇、2022年7月在布鲁克林、2024年3月在TANDEM招收患者;于2023年4月完成布鲁克林和2023年7月百老汇的注册。该公司还于2022年3月启动了PREVIAL心血管预后3期试验,该试验旨在评估obicetrapib在减少重大心血管不良事件发生方面的潜力,包括心血管死亡、非致命性心肌梗塞、非致命性中风和非选择性冠状动脉血运重建。新阿姆斯特丹于2024年4月完成了PREVAIL的入组,并随机抽取了9,500多名患者。

About NewAmsterdam
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. 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.

关于新阿姆斯特丹
NewAmsterdam Pharma(纳斯达克股票代码:NAMS)是一家处于后期阶段的生物制药公司,其使命是改善目前批准的疗法不足或耐受性不佳的代谢性疾病患者的患者护理。我们力求满足对安全、耐受性好和便捷的降低密度脂蛋白疗法的巨大未满足的需求。在多项3期研究中,NewAmsterdam正在研究obicetrapib,一种口服、低剂量、每日一次的CETP抑制剂,单独使用或与依泽替米贝作为固定剂量联合疗法,可用作他汀类药物治疗的辅助疗法,用于低密度脂蛋白C升高的心血管疾病风险患者,现有疗法不够有效或耐受性不佳。

Forward-Looking Statements
Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the Company's business and strategic plans, the Company's commercial opportunity, the therapeutic and curative potential of the Company's product candidate, the Company's clinical trials and the timing for enrolling patients, the timing and forums for announcing data, the achievement and timing of regulatory approvals, and plans for commercialization. These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the Company's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to the approval of the Company's product candidate and the timing of expected regulatory and business milestones, including potential commercialization; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; global economic and political conditions, including the Russia-Ukraine and Israel-Hamas conflict; the effects of competition on the Company's future business; and those factors described in the Company's public filings with the Securities Exchange Commission. Additional risks related to the Company's business include, but are not limited to: uncertainty regarding outcomes of the Company's ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Company's efforts to commercialize a product candidate; the Company's ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company's business; intellectual property related claims; the Company's ability to attract and retain qualified personnel; ability to continue to source the raw materials for its product candidate. If any of these risks materialize or the Company's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company's expectations, plans, or forecasts of future events and views as of the date of this document and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company's assessments to change. These forward-looking statements should not be relied upon as representing the Company's assessment as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law.

前瞻性陈述
就1995年《美国私人证券诉讼改革法》的安全港条款而言,本文件中包含的某些非历史事实的陈述是前瞻性陈述。前瞻性陈述通常附有 “相信”、“可能”、“将”、“估计”、“继续”、“预测”、“打算”、“预期”、“应该”、“将”、“计划”、“预测”、“潜在”、“看起来”、“寻找”、“未来”、“展望” 等词语以及预测或表明未来事件或趋势或不是历史问题陈述的类似表达。这些前瞻性陈述包括但不限于有关公司业务和战略计划、公司的商业机会、公司候选产品的治疗和治疗潜力、公司的临床试验和入院时间、公布数据的时间和论坛、监管部门批准的实现和时机以及商业化计划的陈述。这些陈述基于各种假设,无论是否在本文件中提出,也基于公司管理层当前的预期,不是对实际业绩的预测。这些前瞻性陈述仅用于说明目的,无意作为担保、保证、预测或对事实或概率的明确陈述,也不得将其作为担保、保证、预测或最终陈述。实际事件和情况很难或不可能预测,可能与假设不同。许多实际事件和情况是公司无法控制的。这些前瞻性陈述受许多风险和不确定性的影响,包括国内外业务、市场、财务、政治和法律条件的变化;与公司候选产品的批准以及预期监管和业务里程碑的时机相关的风险,包括潜在的商业化;与潜在客户谈判最终合同安排的能力;竞争产品候选人的影响;获得充足材料供应的能力;全球经济和政治条件,包括俄罗斯-乌克兰和以色列-哈马斯冲突;竞争对公司未来业务的影响;以及公司向证券交易委员会提交的公开文件中描述的因素。与公司业务相关的其他风险包括但不限于:公司正在进行的临床试验结果的不确定性,尤其是与监管审查和候选产品的潜在批准有关的不确定性;与公司努力将候选产品商业化相关的风险;公司以优惠条件进行谈判和达成最终协议的能力(如果有的话);竞争产品候选产品对公司业务的影响;知识产权相关索赔;公司的能力吸引和留住合格的人员;能够继续为其候选产品采购原材料。如果其中任何风险得以实现或公司的假设被证明不正确,则实际结果可能与这些前瞻性陈述所暗示的结果存在重大差异。可能还存在公司目前不知道或公司目前认为不重要的其他风险,这些风险也可能导致实际业绩与前瞻性陈述中包含的结果有所不同。此外,前瞻性陈述反映了截至本文件发布之日公司对未来事件和观点的预期、计划或预测,并参照此处的警示性陈述对其进行了全面限定。公司预计,随后的事件和事态发展可能会导致公司的评估发生变化。不应将这些前瞻性陈述视为本通信之日后任何日期的公司评估。因此,不应过分依赖前瞻性陈述。除非法律要求,否则公司及其任何关联公司均不承担任何更新这些前瞻性陈述的义务。

Company Contact
Matthew Philippe
P: 1-917-882-7512
matthew.philippe@newamsterdampharma.com

公司联系人
马修·菲利普
P:1-917-882-7512
matthew.philippe@newamsterdampharma.com

Media Contact
Spectrum Science on behalf of NewAmsterdam
Jenn Gordon
P: 1-202-957-7795
jgordon@spectrumscience.com

媒体联系人
代表新阿姆斯特丹的频谱科学
珍·戈登
P:1-202-957-7795
jgordon@spectrumscience.com

Investor Contact
Stern Investor Relations on behalf of NewAmsterdam
Hannah Deresiewicz
P: 1-212-362-1200
hannah.deresiewicz@sternir.com

投资者联系人
Stern 投资者关系部代表 NewAmsterdam
汉娜·德雷西维奇
P: 1-212-362-1200
hannah.deresiewicz@sternir.com


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