Obicetrapib

-- Additional data from BROADWAY, BROOKLYN, and TANDEM to be presented throughout 2025; expected to support global regulatory filings for obicetrapib, including EMA submission in 2H25 by our partner Menarini – -- Data from Phase 2 VINCENT trial expected by 2H25, which explores effect of obicetrapib alone and in combination with a PCSK9i on Lp(a) – -- Focus on commercial readiness with manufacturing capacity establishment and inventory build-out -- -- Year end, unaudited, cash balance of $835 million following oversubscribed public offering in December 2024 -- NAARDEN, The Netherlands and MIAMI, Jan. 10, 2025 (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 provided an update on the obicetrapib clinical development program and outlined its strategic priorities for 2025. NewAmsterdam is developing obicetrapib, an oral, low-dose, once-daily, and highly selective cholesteryl ester transfer protein (“CETP”) inhibitor, alone or as a fixed-dose combination with ezetimibe, as preferred LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of cardiovascular disease with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. The Company’s global, pivotal Phase 3 clinical development program consists of four trials in over 12,250 patients. "2024 was a landmark year for NewAmsterdam, underscored by exceptional clinical and operational execution. We announced positive topline results from three pivotal Phase 3 trials, BROOKLYN, TANDEM, and BROADWAY, which will form the foundation for our planned global regulatory filings for obicetrapib,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We were particularly excited to announce results from BROADWAY, which demonstrated greater than expected reduction in the exploratory outcome measure of major adverse cardiovascular events (“MACE”) after only one year of treatment with obicetrapib, with a safety profile that was comparable to placebo. These data not only reinforce obicetrapib’s potential to both lower LDL-C and address critical cardiovascular risks, but also support the approach we have taken for our ongoing PREVAIL Phase 3 cardiovascular outcomes trial (“CVOT”), which is designed to assess MACE benefit as its primary endpoint.” “As we move into 2025, we are focused on sharing additional scientific findings on obicetrapib’s therapeutic potential through presentations at leading medical meetings and publications in high-impact journals, and on advancing PREVAIL toward a successful data readout. Importantly, following our recent financing, we are operating from a position of financial strength, with capital to support operations through the anticipated PREVAIL CVOT readout and, pending regulatory approval, the commercial launch of obicetrapib. We believe we are at the precipice of a major transformation for CVD care globally and remain steadfast in our mission to unlock the full potential of obicetrapib for the millions of people living with dyslipidemia and at heightened risk for CVD,” continued Dr. Davidson. Key 2024 Achievements: NewAmsterdam announced positive topline results for three Phase 3 clinical studies, each with safety comparable to placebo: BROADWAY evaluated obicetrapib in 2,530 adult patients with established atherosclerotic cardiovascular disease (“ASCVD”) and/or heterozygous familial hypercholesterolemia (“HeFH”), whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. In December, NewAmsterdam reported positive topline data from the BROADWAY study. The primary endpoint was the least-squares mean of the percent change in LDL-C from baseline to day 84 for obicetrapib 10 mg compared to placebo. The primary endpoint was achieved with statistical significance with an LDL-C reduction of 33% (p<0.0001). Mean and median reductions in LDL-C at day 84 were 33% and 36%, respectively. As part of the safety analysis, the trial adjudicated MACE, including death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization, and in an exploratory analysis, a 21% reduction in MACE favoring obicetrapib was observed. NewAmsterdam expects to report additional data at an upcoming medical conference and to publish the data in a major medical journal.TANDEM evaluated obicetrapib as part of a fixed-dose combination tablet with ezetimibe, a non-statin oral LDL-lowering therapy, in 407 patients with established ASCVD or multiple risk factors for ASCVD and/or HeFH, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. In November, NewAmsterdam reported that the TANDEM trial met all co-primary endpoints, including the obicetrapib-ezetimibe fixed dose combination achieving an LS mean reduction of 49% (p < 0.0001) compared to placebo at day 84. Mean and median reductions in LDL-C at day 84 were 52% and 54%, respectively. NewAmsterdam expects to report additional data at an upcoming medical conference and to publish the data in a major medical journal.BROOKLYN evaluated obicetrapib in 354 patients with HeFH, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. In July, NewAmsterdam reported that the BROOKLYN trial met its primary endpoint, achieving an LS mean reduction of 36% (p < 0.0001) compared to placebo at day 84, with additional data presented at the American Heart Association Scientific Sessions 2024 in November. Mean and median reductions in LDL-C at day 84 were 36% and 39%, respectively.PREVAIL is a cardiovascular outcomes trial evaluating obicetrapib in patients with a history of ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam completed enrollment of over 9,500 patients in April 2024 and the trial continues in line with expectations. In addition, NewAmsterdam announced that the United States Patent and Trademark Office (“USPTO”) issued a new patent covering the solid form that will be used in the Company’s products. The issuance of this composition of matter patent provides intellectual property protection for obicetrapib until July 2043 in the United States. The USPTO has now issued or allowed a total of nine patents covering obicetrapib and its uses. Key 2025 Milestones and Ongoing Trials: Over the course of 2025, NewAmsterdam plans to announce additional data from its Phase 3 studies, including BROADWAY, TANDEM, and BROOKLYN. NewAmsterdam also plans to publish data on a significant number of topics that support the overall benefit and differentiation of obicetrapib and the fixed dose combination of obicetrapib plus ezetimibe, compared to other lipid lowering therapies. In addition to PREVAIL, NewAmsterdam continues to enroll two studies of obicetrapib, including: VINCENT, a Phase 2 clinical study to evaluate the effects of obicetrapib alone and in combination with evolocumab on lipoprotein (a) (“Lp(a)”) in patients with mild dyslipidemia. The single arm study will treat patients with obicetrapib 10mg daily for 8 weeks followed by obicetrapib 10mg daily plus evolocumab 140 mg/dL every other week for 8 weeks. The study is expected to complete in the second half of 2025 and to enroll 30 patients with baseline Lp(a) levels above 50 mg/dL.REMBRANDT, a Phase 3 cardiovascular computed tomography angiography imaging trial to evaluate the effect of obicetrapib plus ezetimibe FDC on coronary plaque. The placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics. The study is expected to complete in 2027 and to enroll 300 patients. An additional focus for the Company throughout 2025 will be on commercial manufacturing and readiness. The Company plans to scale up and build inventory sufficient for both the U.S. and European launches, if approved, which will be supported by the approximately $835 million of unaudited cash on hand at year-end 2024. About Obicetrapib Obicetrapib is a novel, oral, low-dose, and highly selective 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, as well as the Company’s Phase 3 BROOKLYN, BROADWAY and TANDEM trials, 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 currently conducting the Phase 3 PREVAIL cardiovascular outcomes trial, 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. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed dose combination with ezetimibe, for cardiovascular diseases have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company. About Cardiovascular Disease Cardiovascular disease remains the leading cause of death globally, despite the availability of lipid-lowering therapies (LLTs). By 2050 more than 184 million US adults are expected to be affected by CVD and hypertension, including 27 million with coronary heart disease and 19 million with stroke. In the United States from 2019 through 2022, CVD age-adjusted mortality rates increased 9%, reversing the trend observed since 2010 and undoing nearly a decade of progress. Despite the availability of high-intensity statins and non-statin LLTs, LDL-C target level attainment remains low, contributing to residual cardiovascular risk, and underscoring a significant clinical need for improved therapeutic regimens. Even with 269 million LLT prescriptions written over the last 12 months, 30 million under-treated US adults are not at their risk-based LDL-C goal, of which 13 million have ASCVD. Less than 1 in 4 patients with ASCVD achieve an LDL-C goal of less than 70mg/dL and only 10% of very high risk ASCVD patients achieve the goal below 55 mg/dL. In addition to the 30 million under-treated US adults, there are 10 million patients diagnosed with elevated LDL-C who are not taking any LLTs including statins. Beyond LDL-C, additional factors are at play, such as lifestyle choices, tobacco use, and obesity, as well as inflammation, thrombosis, triglyceride levels, elevated Lp(a) levels, and type 2 diabetes. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage, clinical 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 trials, 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. 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; whether topline, initial or preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, or whether projections regarding clinical outcomes will reflect actual results in future clinical trials or clinical use of our product candidate, if approved; 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; and ability to continue to source the raw materials for the Company’s 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. Company ContactMatthew PhilippeP: 1-917-882-7512matthew.philippe@newamsterdampharma.com Media ContactSpectrum Science on behalf of NewAmsterdamJaryd LeadyP: 1-856-803-7855jleady@spectrumscience.com Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP: 1-212-698-8696austin.murtagh@precisionaq.com

– 两项关键性 研究均在最大耐受性脂质调节疗法的基础上，实现了LDL-C最小二乘均值的降低，达到了主要终点，并且具有高度的统计学意义（p<0.0001） – 在BROADWAY（Obicetrapib单药治疗）试验中， 约50% 的患者 以及 在TANDEM（Obicetrapib与Ezetimibe的固定剂量组合）试验中，超过70%的患者达到了LDL-C低于55 mg/dL的目标 – 在BROADWAY试验中，使用 Obicetrapib 治疗的患者，其主要不良心血管事件的发生率在一年内降低了21% -- 在这两项研究中，Obicetrapib单药治疗以及与 Ezetimibe 的固定剂量组合均表现出良好的耐受性 意大利佛罗伦萨 2024年12月18日 /美通社/ -- Menarini Group今天宣布了由NewAmsterdam Pharma Company N.V.（纳斯达克股票代码：NAMS；或称为“NewAmsterdam”或“公司”）赞助的两项临床3期试验——BROADWAY（NCT05142722）和TANDEM（NCT06005597）的积极顶线数据。NewAmsterdam是一家处于临床后期的生物制药公司，专注于为那些现有疗法效果不佳或耐受性差的心血管疾病（CVD）患者，特别是那些低密度脂蛋白胆固醇（LDL-C）水平升高的患者，开发口服非他汀类药物。 BROADWAY临床3期试验（NCT05142722）旨在评估10毫克Obicetrapib对于成年患者的疗效，这些患者患有杂合子家族性高胆固醇血症（HeFH）和/或已确诊的动脉粥样硬化性心血管疾病（ASCVD），尽管他们已经接受了最大耐受量的降脂治疗，但其LDL-C水平仍未得到充分控制。 TANDEM临床3期试验（NCT06005597）旨在评估10毫克Obicetrapib和10毫克Ezetimibe固定剂量组合对患有HeFH和/或ASCVD或多种ASCVD风险因素的成年患者的影响，这些患者尽管接受了最大耐受量的降脂治疗，但其LDL-C水平仍未得到充分控制。 在BROADWAY试验中，主要终点是比较10毫克Obicetrapib与安慰剂相比，从基线到第84天时LDL-C百分比变化的最小二乘均值。 主要终点已达到统计学显著性标准，表现为LDL-C降低33%（p<0.0001）。 第84天LDL-C百分比变化： Placebo (n=844) Obicetrapib 10 mg (n=1686) Difference Mean -2 % -35 % -33 % Median -4 % -40 % -36 % LS mean +3 % -30 % -33 % 观察到的其他生物标志物变化，包括高密度脂蛋白胆固醇（HDL-C）水平的升高，以及非HDL-C、脂蛋白(a)（Lp(a)）、载脂蛋白B（ApoB）和载脂蛋白A1（ApoA1）水平的降低，均呈现积极趋势，且与先前临床试验的数据一致。 作为安全性分析的一部分，重点监测了特别关注的关键不良事件（AE）。 在这些不良事件中，Obicetrapib未对血糖控制和肾功能产生负面影响。 此外，BROADWAY试验对包括死亡、非致命性心肌梗死、非致命性中风和冠状动脉血运重建在内的主要不良心血管事件（MACE）进行了裁定，结果显示， 使用Obicetrapib的患者在这些事件上的风险降低了21%。 主要不良心血管事件表： Placebo (n = 844) Obicetrapib 10 mg (n= 1686) Hazard Ratio 95% CI All-cause mortality – no. (%) 12 (1.4) 19 (1.1) 0.83 (0.40-1.71) Coronary heart death – no. (%) 5 (0.6) 8 (0.5) 0.80 (0.26-2.44) First 4-point MACE – no. (%) 44 (5.2) 70 (4.2) 0.79 (0.54-1.15) 4-point MACE： 包括 死亡、非致命性心肌梗死、非致命性中风、冠状动脉血运重建 。 MACE并非BROADWAY试验的主要或次要评估终点。 总体而言，Obicetrapib显示出良好的耐受性，其安全性数据（包括血压水平）与安慰剂组相当。 Obicetrapib组的治疗中断率为11.1%，安慰剂组为12.4%。 下表总结了治疗期间新出现的不良事件（TEAE）、与研究药物相关的TEAE，以及治疗期间新出现的严重不良事件（TESAE）的发生率。 Placebo (n=8 43) Obicetrapib 10 mg (n=1 ,685) Any TEAEs – no. (%) 513 (60.9) 1007 (59.8) Any trial drug related TEAEs – no (%) 39 (4.6) 76 (4.5) Any TEAEs leading to discontinuation of trial drug – no. (% 43 (5.1) 68 (4.0) Any TESAEs – no. (%) 117 (13.9) 211 (12.5) TANDEM试验的共同主要终点包括：在治疗84天后，固定剂量组合与每种单药治疗组相比，LDL-C水平相对于基线的百分比变化；以及在第84天后，10毫克Obicetrapib与安慰剂相比的LDL-C水平变化。 次要终点包括其他生物标志物相对于基线的百分比变化，涵盖了Lp(a)、非HDL-C和APO B等。 TANDEM试验成功达成了所有共同主要终点，其中，固定剂量组合Obicetrapib与Ezetimibe在第84天实现了相较于安慰剂的最小二乘均值降低48.6%的显著效果（p < 0.0001）。 第84天LDL-C百分比变化 Ezetimibe (n=101) Obicetrapib (n=102) Obicetrapib and Ezetimibe FDC (n=102) Day 84 – from placebo Mean % -23.3 -35.5 -52.2 Median % -22.6 -37.2 -54.0 LS mean % -20.7 -31.9 -48.6 Comparison to pbo - (p<0.0001) (p<0.0001) Comparison to eze 10 mg - - (p<0.0001) Comparison to obi 10 mg - - (p=0.0007) 在试验中，Obicetrapib和Ezetimibe的固定剂量组合表现出良好的耐受性，安全性数据与安慰剂相当。 下表总结了与研究药物相关的治疗期间新出现的不良事件（TEAE）和严重不良事件（TESAE）。 Placebo (n=102) Ezetimibe (n=101) Obicetrapib (n=102) Obicetrapib / Ezetimibe FDC (n=102) Any study drug-related TEAEs 4 (3.9 %) 3 (3.0 %) 7 (6.9 %) 3 (2.9 %) Any study drug-related TEAEs leading to discontinuation of study drug 2 (2.0 %) 1 (1.0 %) 6 (5.9 %) 1 (1.0 %) Any study drug related TESAEs 0 (0.0 %) 0 (0.0 %) 0 (0.0 %) 0 (0.0 %) “心血管疾病（CVD）是导致全球死亡的首要原因，估计每年夺走1,790万人的生命。 尽管降脂疗法已广泛应用，但与心血管疾病相关的死亡人数仍在上升，患者的LDL-C水平仍高于目标值，许多患者未能达到指南推荐的LDL.C目标。 患者及其医生需要更多的选择。 我们非常高兴，BROADWAY和TANDEM数据以及之前公布的BROOKLYN数据证实，Obicetrapib作为单药治疗或与Ezetimibe固定剂量组合，能够显著降低LDL-C水平，并帮助患者达到推荐的治疗目标。 这是我们承诺为欧洲心血管疾病患者提供服务的一个重要里程碑，也是抗击心血管疾病的潜在首创低剂量、每日一次口服治疗的开端，更是我们公司30多年来的使命。” Menarini Group首席执行官Elcin Barker Ergun表示 。 BROADWAY关键性临床3期试验设计 这项为期52周的全球性关键性3期随机双盲安慰剂对照多中心研究，评估了10毫克Obicetrapib作为最大耐受量降脂疗法的辅助治疗，与安慰剂相比，在LDL-C未得到充分控制的ASCVD和/或HeFH患者中的疗效和安全性。 该研究在北美、欧洲、亚洲和澳大利亚的多个地点进行。 共有2,530名患者按2:1的比例随机分配，接受10毫克Obicetrapib或安慰剂，每日一次口服给药，可在就餐时服用，也可空腹服用，持续52周。 尽管在筛查期间近70%的患者报告使用高强度他汀类药物，但Obicetrapib治疗组患者的平均基线LDL-C水平约为100 mg/dL。 女性约占研究人群的34%，基线时参与者的中位年龄为65岁。 主要终点是与安慰剂相比，10毫克Obicetrapib在84天后LDL-C相对于基线的百分比变化，插补分析显示降低33%。 次要终点包括与安慰剂相比，10毫克Obicetrapib在第84天时ApoB、Lp(a)、ApoA1、HDL-C、非HDL-C、总胆固醇和甘油三酯的基线百分比变化，以及在第180天和第365天LDL-C水平的百分比变化（分别为-34%和-24%，且p<0.0001）。 其他结果指标包括从随机化到首次确认Obicetrapib组与安慰剂相比发生MACE的时间。 该试验还评估了Obicetrapib的安全性和耐受性情况。 TANDEM关键性临床3期试验设计 这项关键性的3期随机双盲四组安慰剂对照多中心研究，评估了10毫克Obicetrapib与10毫克Ezetimibe固定剂量组合对LDL-C水平的影响，并与10毫克Ezetimibe、10毫克Obicetrapib单药治疗及安慰剂进行了比较。 该研究在美国多个研究中心进行，共纳入407名患者，这些患者患有HeFH和/或ASCVD，或ASCVD风险等效症，且基线LDL-C水平至少为70 mg/dL。患者按1:1:1:1的比例随机分配，接受10毫克Obicetrapib与10毫克Ezetimibe固定剂量组合、10毫克Obicetrapib、10毫克Ezetimibe或安慰剂，治疗期为84天。 尽管约74%的患者在筛查期间报告高强度使用他汀类药物，但Obicetrapib-Ezetimibe治疗组患者的平均基线LDL-C为97 mg/dL。 除了测量共同主要终点和次要终点外，该试验还对Obicetrapib的安全性和耐受性进行了评估。 Obicetrapib的全球关键性3期项目 Obicetrapib全球关键性3期临床开发项目包括四项研究，涉及12,250多名患者，其中三项研究针对Obicetrapib单药治疗，一项针对Obicetrapib与Ezetimibe的固定剂量复方制剂（FDC） ： BROOKLYN评估了Obicetrapib对HeFH患者的疗效，这些患者尽管接受了最大耐受量的降脂治疗，但其LDL-C水平仍未得到充分控制（NCT05425745）。 该研究于2023年4月完成了350多名患者的入组工作。 2024年第三季度报告的顶线数据。 BROADWAY评估了Obicetrapib在已确诊ASCVD和/或HeFH的成年患者中的疗效，这些患者尽管正在接受最大耐受量的降脂治疗，但其LDL-C水平仍未得到充分控制（NCT05142722）。 该研究于2023年7月完成了2,500多名患者的入组工作。 该公司于2024年第四季度报告的顶线数据。 TANDEM评估了Obicetrapib作为FDC片剂的一部分，与非他汀类口服降低LDL疗法药物Ezetimibe联合使用，针对已确诊的ASCVD患者或存在多种ASCVD风险因素及/或HeFH的患者，这些患者尽管接受了最大耐受量的降脂治疗，但LDL-C仍未得到充分控制（NCT06005597）。  该研究于2024年7月完成了400多名患者的入组工作。 2024年11月报告的顶线数据 PREVAIL是一项心血管预后试验（CVOT），旨在评估Obicetrapib对于有ASCVD病史的患者的疗效，这些患者尽管接受了最大耐受量的降脂治疗，但其LDL-C水平仍未得到充分控制（NCT05202509）。 该研究于2024年4月完成了9,500多名患者的入组工作。 关于Obicetrapib Obicetrapib是一种正在开发的新型口服低剂量CETP抑制剂，旨在克服目前降低LDL疗法的局限性。 在ROSE2、TULIP、ROSE等2期试验，以及BROOKLYN、BROADWAY和TANDEM等3期试验中，评估了Obicetrapib作为单药治疗或联合治疗的效果，结果显示，Obicetrapib在统计学上具有显著降低LDL的作用，且其副作用与安慰剂相似。 3期研究心血管结果试验PREVAIL于2022年3月启动，旨在评估Obicetrapib降低主要不良心血管事件发生率的潜力，包括心血管死亡、非致死性心肌梗死、非致死性中风和非选择性冠状动脉血运重建。 PREVAIL的入组工作于2024年4月完成，随机分配了9,500多名患者。 关于Menarini Group Menarini Group是一家领先的跨国制药及诊断公司，营业额达47亿美元，员工超过17,000人。 公司专注于未满足需求较高的治疗领域，产品涉及心脏病、肿瘤、肺病、肠胃病、传染病、糖尿病、炎症和镇痛。 Menarini拥有18个生产基地和9个研发中心，产品畅销全球140个国家和地区。 如需了解更多信息，请访问 www.menarini.com。 关于NewAmsterdam 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，致力于改善代谢性疾病患者的治疗效果，尤其是在现有疗法不足或耐受性差的领域。 我们力求满足对安全、耐受性佳、便捷的降低LDL疗法的巨大需求。 在多项3期研究中，NewAmsterdam正在研究Obicetrapib，这是一种口服、低剂量、每日一次的CETP抑制剂。该药物可以单独使用，也可以与Ezetimibe组成固定剂量组合，作为降低LDL-C的疗法。这些疗法旨在作为他汀类药物的辅助治疗，适用于LDL-C水平升高且存在CVD风险的患者，尤其是对于那些现有疗法效果不佳或耐受性差的患者。