– Met Primary Endpoint with 63.4% Median Reduction in LDL-C (p<0.0001) –
– 87.1% of Patients Treated with Combination of Obicetrapib and Ezetimibe Met Guideline-Recommended LDL-C Goal of <55 mg/dL compared to 0% of Patients Treated with Placebo (p<0.05) –
– New Data Demonstrate Statistically Significant and Clinically Meaningful Improvements in Additional Lipid and Lipoprotein Parameters Predictive of Cardiovascular Disease Risk, Such as LDL Particles and Lipoprotein(a) –
– Favorable Safety and Tolerability Observed –
– Selected Fixed-Dose Combination Tablet Formula; Phase 3 Trial Expected to Initiate 1Q 2024 –
– Management to Host Conference Call at 8:00 a.m. ET on Monday, June 5, 2023 –
NAARDEN, the Netherlands and MIAMI, June 03, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or "NewAmsterdam" or the "Company"), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease ("CVD") with residual elevation of low-density lipoprotein cholesterol ("LDL-C" or "LDL"), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the full results of ROSE2, a Phase 2 clinical trial evaluating obicetrapib, the Company's oral, low-dose and once-daily cholesteryl ester transfer protein ("CETP") inhibitor, in combination with ezetimibe as an adjunct to high-intensity statin therapy. The data are being presented in an oral late-breaker presentation today at the National Lipid Association ("NLA") Scientific Sessions 2023 and will be published concurrently in the Journal of Clinical Lipidology.
ROSE2 met its primary and secondary endpoints, with statistically significant and clinically meaningful reductions in LDL-C and apolipoprotein B ("ApoB") observed. Statistically significant improvements in lipoprotein(a) ("Lp(a)"), non-HDL cholesterol ("non-HDL-C") and total and small LDL particles were also observed. In addition, the combination of obicetrapib and ezetimibe was observed to be well-tolerated, with a safety profile observed to be comparable to placebo. With these data in hand, the Company has selected a formulation for a fixed-dose combination tablet and intends to advance the compound into a Phase 3 trial in the first quarter of 2024.
"The 2022 ACC Expert Consensus Decision Pathway has recommended that very high risk patients with LDL-C above 55mg/dl need additional therapy to maximize proven risk reduction. With these new recommendations, many more patients will fail to achieve guideline-mandated LDL-C goals, demonstrating the limitations of existing therapeutics and the critical need for new options," said Christie M. Ballantyne, M.D., Chief of Cardiovascular Research and Professor at Baylor College of Medicine and principal investigator on the clinical trial. "The data presented today are highly encouraging, showing that the combination of obicetrapib and ezetimibe delivers robust impacts on multiple atherogenic lipid parameters. I believe the observed reductions in LDL-C, ApoB, Lp(a) and total and small LDL particles are potentially predictive of profound reductions in the risk of cardiovascular events and look forward to further characterizing the combination obicetrapib and ezetimibe regimen in a Phase 3 trial."
"The ROSE2 data build on our prior clinical experience, supporting the potential for obicetrapib to become a new standard-of-care combined safely with existing options to deliver improved outcomes to the millions of very high-risk patients in need. We are particularly encouraged by the new goal attainment data announced today, through which we observed that 87 percent of patients treated with the combination regimen of obicetrapib and ezetimibe met the most aggressive guideline-mandated LDL-C target of <55 mg/dL," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam, "We have selected a fixed-dose combination tablet formula and look forward to advancing it into a Phase 3 trial, targeted to commence in the first quarter of 2024. In addition, we continue to progress our ongoing BROADWAY, BROOKLYN and PREVAIL trials according to plan. We believe that clinicians and patients are seeking oral options in addition to maximally tolerated statin therapy to reduce the risk of cardiovascular disease. Obicetrapib 10mg as monotherapy and in a fixed dose combination with ezetimibe, if successful in our Phase 3 trials, could well be the therapeutic solution that is so sorely needed."
Full Data from the Phase 2 ROSE2 Clinical Trial of Obicetrapib and Ezetimibe
ROSE2 (NCT05266586) was designed as a placebo-controlled, double-blind, randomized Phase 2 clinical trial to evaluate the efficacy, safety and tolerability of obicetrapib 10 mg in combination with ezetimibe 10 mg as an adjunct to high-intensity statin therapy. Patients were randomized to receive combination therapy, obicetrapib 10 mg or placebo for a 12 week treatment period. A total of 119 patients enrolled in ROSE2, of which 97 were included in the on-treatment analysis. Patients presented at baseline with a fasting LDL-C greater than 70 mg/dL and triglycerides ("TG") less than 400 mg/dL and all were receiving a stable dose of high-intensity statin therapy.
The primary endpoint was the percent change from baseline to week 12 in Friedewald-calculated LDL-C for the obicetrapib plus ezetimibe combination treatment group compared with placebo. Secondary efficacy endpoints included the percent changes from baseline to week 12 in LDL-C for obicetrapib monotherapy compared with placebo and in ApoB for the obicetrapib plus ezetimibe combination compared with placebo and the obicetrapib monotherapy compared with placebo. Exploratory endpoints included the percent changes from baseline to week 12 in Lp(a), non-HDL-C, HDL-C, total and small LDL particles assessed by NMR, and the proportion of patients at the end of treatment who achieved LDL-C levels below 100 mg/dL, 70 mg/dL and 55 mg/dL for the obicetrapib plus ezetimibe combination and obicetrapib monotherapy groups compared with placebo.
The p-value for the LS mean for each endpoint compared to placebo was <0.0001. The table below shows the median percent change from baseline in patients receiving the combination of obicetrapib and ezetimibe, obicetrapib monotherapy and placebo.
Median percent change from baseline | Placebo (n=40) | Obicetrapib 10mg (n=26) | Obicetrapib 10 mg + Ezetimibe 10 mg (n=31) |
Friedewald-calculated LDL-C | -6.4 | -43.5 | -63.4 |
ApoB | -2.1 | -24.2 | -34.4 |
Non-HDL-C | -5.6 | -37.5 | -55.6 |
Total LDL particles | -5.7 | -54.8 | -72.1 |
Small LDL particles | -8.3 | -92.7 | -95.4 |
LDL particle size | -0.5 | 1.5 | 1.8 |
The combination of obicetrapib plus ezetimibe resulted in significantly more patients achieving LDL-C levels of less than 100, less than 70 and less than 55 mg/dL than the placebo group (100%, 93.5% and 87.1% vs. 66.7%, 16.7% and 0.0%, respectively) (p<0.05 vs. placebo for all). In addition, we observed a median reduction in Lp(a) of 47.2% and 40.2% in the monotherapy and combination arms, respectively.
Treatment with the combination of obicetrapib and ezetimibe was observed to be generally well-tolerated, with a safety profile comparable to placebo. Adverse events were generally mild to moderate, with the most prevalent adverse events being nausea, urinary tract infection and headache, and no drug-related, treatment-emergent serious adverse events were observed.
"We are particularly encouraged by the new lipid particle analysis, in which we observed reductions in Lp(a) and both total and small LDL particles in patients who received the combination of obicetrapib and ezetimibe," said John Kastelein, M.D., Ph.D., FESC, Chief Scientific Officer of NewAmsterdam. "An observed reduction of almost 50% in Lp(a) levels and associated reduction of 95% in the highly atherogenic small LDL particles are potentially clinically relevant, as LDL particles are believed to be one of the most robust predictors of cardiovascular disease risk. Together, these data further reinforce the potential for obicetrapib to transform the treatment landscape."
Under the terms of NewAmsterdam's licensing agreement with the Menarini Group, data from the ROSE2 trial triggered a clinical success milestone payment to NewAmsterdam, which was received in April 2023.
Conference Call Information
NewAmsterdam will host a live conference call on Monday, June 5, 2023 beginning at 8:00 a.m. ET to review the full data from the Phase 2 ROSE2 clinical trial. Participants may register for the conference call here. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start.
A live webcast of the call will also be available under "Events & Presentations" in the Investors & News section of the Company's website at
About Obicetrapib
Obicetrapib is a next-generation, oral, low-dose CETP inhibitor that NewAmsterdam is developing to potentially overcome the limitations of current LDL-lowering treatments. The Company believes that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if approved. In the Company's Phase 2b ROSE trial, obicetrapib demonstrated a 51% lowering of LDL-C from baseline at a 10 mg dose level on top of high-intensity statins and, in the Company's Phase 2 ROSE2 trial, the combination of a 10 mg dose of obicetrapib and a 10 mg dose of ezetimibe demonstrated a 63% lowering of LDL-C from baseline. In all three of the Company's Phase 2 trials, TULIP, ROSE and OCEAN, evaluating obicetrapib as a monotherapy or a combination therapy, the Company observed statistically significant LDL-lowering activity combined with generally moderate side effects and no drug-related, treatment-emergent serious adverse events. Obicetrapib has demonstrated strong tolerability in more than 600 patients with low or elevated lipid levels ("dyslipidemia") in NewAmsterdam's clinical trials to date. 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 potentially enhance LDL-lowering for high-risk CVD patients. The Company began enrolling patients in BROADWAY in January 2022 and in BROOKLYN in July 2022 and completed enrollment of BROOKLYN ahead of schedule in April 2023. The Company also commenced the Phase 3 PREVAIL CVOT in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization.
About NewAmsterdam
NewAmsterdam (Nasdaq: NAMS) is a clinical-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been sufficiently successful or well tolerated. NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, as the preferred LDL-C lowering therapy to be used as an adjunct to maximally tolerated statin therapy for high-risk cardiovascular disease ("CVD") patients. Results from NewAmsterdam's ROSE Phase 2b trial (presented at AHA Scientific Sessions in 2021) included observations that patients receiving obicetrapib 10 mg experienced a median reduction in LDL-C of 51% versus baseline in patients on high-intensity statin therapy (vs. a 7% reduction in the placebo arm). In addition, results from NewAmsterdam's ROSE2 trial evaluating the combination of 10 mg obicetrapib and 10 mg ezetimibe demonstrated a median reduction in LDL-C levels of 63% versus baseline in patients on high-intensity statin therapy (vs. a 6% reduction in the placebo arm). Based in the Netherlands, NewAmsterdam recently completed a business combination with Frazier Lifesciences Acquisition Corporation ("FLAC"), a special purpose acquisition company sponsored by an affiliate of Frazier Healthcare Partners. Proceeds from this transaction were approximately $328 million, prior to deducting transaction expenses. In June 2022, NewAmsterdam entered into an exclusive licensing agreement with the Menarini Group for the commercialization of obicetrapib in Europe, while retaining all rights to commercialize obicetrapib, if approved, in the rest of the world, as well as rights to develop certain forms of obicetrapib for other diseases such as Alzheimer's disease. For more information, please visit: .
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," "will," "continue," "anticipate," "intend," "expect," "predict," "potential," "seek," "target" 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 clinical trials and the timing for enrolling patients (including commencement of its Phase 3 trial), the timing and forums for announcing data and the achievement and timing of regulatory approvals. 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 relating to the uncertainty of the projected financial information with respect to the Company; risks related to the approval of the Company's product candidate and the timing of expected regulatory and business milestones; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; the impact of COVID-19; global economic and political conditions, including the Russia-Ukraine conflict; the effects of competition on the Company's future business; and those factors described in the Company's public filings with the U.S. Securities and 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.
Company Contact
Matthew Philippe
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
Investor Contact
Stern Investor Relations on behalf of NewAmsterdam
Hannah Deresiewicz
P: 1 212-362-1200
hannah.deresiewicz@sternir.com
-Met主要终点,低密度脂蛋白-C降低了63.4%(p<0.0001)-
-87.1%的患者接受ObicetRapib和Ezetimibe Met指南的联合治疗-建议的低密度脂蛋白目标<55 mg/dL,而接受安慰剂治疗的患者的这一比例为0%(p<0.05)-
-新数据显示,在预测心血管疾病风险的其他血脂和脂蛋白参数方面,如低密度脂蛋白颗粒和脂蛋白(A),有统计上显著和临床上有意义的改善。
-观察到良好的安全性和耐受性-
-精选固定剂量联合片剂配方;第三阶段试验预计将于2024年第一季度启动-
-管理层将于上午8:00主持电话会议。美国东部时间2023年6月5日星期一-
荷兰纳尔登和迈阿密,2023年6月3日(环球网)--新阿姆斯特丹制药公司(纳斯达克:NAMS或“新阿姆斯特丹”或“公司”),一家临床阶段的生物制药公司,为心血管疾病(“CVD”)的高风险患者(“低密度脂蛋白胆固醇”或“低密度脂蛋白胆固醇”)残留升高的患者开发口服非他汀类药物,对现有治疗方法不够有效或耐受性不佳的患者,今天宣布了ROSE2的全部结果,这是一项评估obicetRapib的第二阶段临床试验,低剂量和每日一次的胆固醇酯转移蛋白(“CETP”)抑制剂,与依折麦布联合作为高强度他汀类药物的辅助治疗。这些数据将于今天在2023年全国脂质协会(NLA)科学会议上以口头报告的形式公布,并将同时发表在临床类脂学杂志。
ROSE2达到了其主要和次要终点,观察到低密度脂蛋白-C和载脂蛋白B(“ApoB”)在统计上显著和临床上有意义的降低。在统计上,脂蛋白(A)(“Lp(A)”)、非高密度脂蛋白胆固醇(“非高密度脂蛋白-C”)以及总和小的低密度脂蛋白颗粒也有显著改善。此外,观察到奥比曲布和依折麦布的联合用药耐受性良好,安全性与安慰剂相当。有了这些数据,该公司已经选择了固定剂量联合片剂的配方,并打算在2024年第一季度将该化合物推进到第三阶段试验。
贝勒医学院心血管研究主任、贝勒医学院教授兼临床试验首席研究员克里斯蒂·M·巴兰廷表示:“2022年ACC专家共识决策路径建议,低密度脂蛋白胆固醇高于55毫克/分升的极高风险患者需要额外的治疗,以最大限度地降低已证实的风险。有了这些新的建议,更多的患者将无法实现指南规定的低密度脂蛋白目标,这表明现有疗法的局限性以及对新选择的迫切需要。”今天公布的数据非常令人鼓舞,表明obicetRapib和ezetimibe的组合对多种导致动脉粥样硬化的脂质参数产生了强有力的影响。我相信观察到的低密度脂蛋白-C、载脂蛋白B、Lp(A)以及总和小的低密度脂蛋白颗粒的减少可能预示着心血管事件风险的大幅降低,并期待着在第三阶段试验中进一步描述obicetRapib和ezetimibe的组合方案的特征。
ROSE2数据建立在我们以前的临床经验的基础上,支持obicetRapib成为一种新的护理标准的潜力,与现有的选择安全地结合在一起,为数百万需要的非常高风险的患者提供改善的结果。我们对今天宣布的新的目标实现数据特别感到鼓舞,通过这些数据,我们观察到,接受obicetRapib和ezetimibe联合疗法治疗的患者中,87%达到了指南规定的最激进的<55 mg/dL的低密度脂蛋白-C目标,“纽阿姆斯特丹公司首席执行官迈克尔·戴维森医学博士说,”我们已经选择了一种固定剂量的联合片剂配方,并期待着将其推进到第三阶段试验,目标是在2024年第一季度开始。此外,我们继续推进我们正在进行的百老汇、布鲁克林和胜利者审判按计划进行。我们认为,除了最大耐受性的他汀类药物治疗外,临床医生和患者正在寻求口服治疗方案,以降低心血管疾病的风险。如果在我们的第三阶段试验中成功,ObicetRapib 10 mg作为单一疗法并以固定剂量与ezetimibe联合使用,很可能是非常需要的治疗解决方案。“
ObicetRapib和Ezetimibe的2期ROSE 2期临床试验完整数据
ROSE2(NCT05266586)是一项安慰剂对照、双盲、随机的2期临床试验,目的是评估在高强度他汀类药物治疗的辅助下,奥比曲布10毫克与依折麦布10毫克联合使用的有效性、安全性和耐受性。患者随机接受联合治疗,奥比曲布10毫克或安慰剂,为期12周。共有119名患者在ROSE 2中登记,其中97人进入治疗分析。基线时出现空腹低密度脂蛋白胆固醇大于70 mg/dL,甘油三酯小于400 mg/dL的患者,均接受稳定剂量的高强度他汀类药物治疗。
主要终点是与安慰剂相比,在Friedewald计算的低密度脂蛋白-C(LDL-C)从基线到第12周的百分比变化中,obicetRapib加ezetimibe联合治疗组与安慰剂相比。次要疗效终点包括与安慰剂相比,ObicetRapib单一疗法的低密度脂蛋白-C从基线到第12周的百分比变化,以及与安慰剂相比,obicetRapib+ezetimibe组合的ApoB的百分比变化,以及与安慰剂相比,obicetRapib单一疗法的百分比变化。研究终点包括从基线到第12周的Lp(A)、非高密度脂蛋白-C、高密度脂蛋白-C、总和小低密度脂蛋白颗粒的百分比变化,以及与安慰剂相比,在治疗结束时,与安慰剂相比,奥贝特拉布加依折麦比组和奥贝拉比单用组的低密度脂蛋白-C水平分别低于100 mg/dL、70 mg/dL和55 mg/dL的患者的比例。
与安慰剂相比,每个终点的LS平均值的p值<0.0001。下表显示了接受奥比特拉布和依折麦布联合治疗、奥比特拉布单一治疗和安慰剂治疗的患者与基线相比的中位数百分比变化。
与基线相比的中位数百分比变化 | 安慰剂(n=40) | 奥昔曲布10毫克 (n=26) | 奥比曲布10 镁+依折麦布10 镁(n=31) |
Friedewald计算的低密度脂蛋白胆固醇 | -6.4 | -43.5 | -63.4 |
载脂蛋白B | -2.1 | -24.2 | -34.4 |
非高密度脂蛋白胆固醇 | -5.6 | -37.5 | -55.6 |
低密度脂蛋白颗粒总数 | -5.7 | -54.8 | -72.1 |
小颗粒低密度脂蛋白 | -8.3 | -92.7 | -95.4 |
低密度脂蛋白颗粒大小 | -0.5 | 1.5 | 1.8 |
比起安慰剂组(分别为100.00%、93.5%和87.1%,分别为66.7%、16.7%和0.0%),奥比曲布和依折替比联用组的低密度脂蛋白胆固醇水平低于100、<70和<55 mg/dL的患者显著增多(p<0.05)。此外,我们观察到单一治疗组和联合用药组Lp(A)的中位数分别降低了47.2%和40.2%。
观察到奥比曲布和依折麦布的联合治疗总体上耐受性良好,安全性与安慰剂相当。不良事件一般为轻度至中度,最常见的不良事件是恶心、尿路感染和头痛,没有观察到与药物有关的、治疗紧急的严重不良事件。
纽阿姆斯特丹的首席科学官John Kastelein说:“我们对新的脂质颗粒分析特别感到鼓舞,在这种分析中,我们观察到服用obicetRapib和ezetimibe的患者的Lp(A)以及总和小的低密度脂蛋白颗粒的减少。”观察到的Lp(A)水平降低近50%,以及高度致动脉粥样硬化的小低密度脂蛋白颗粒减少95%具有潜在的临床意义,因为低密度脂蛋白颗粒被认为是心血管疾病风险最可靠的预测因素之一。总之,这些数据进一步加强了奥比特拉比改变治疗格局的潜力。
根据新阿姆斯特丹与梅纳里尼集团的许可协议条款,ROSE2试验的数据触发了向新阿姆斯特丹支付的临床成功里程碑付款,该付款于2023年4月收到。
电话会议信息
新阿姆斯特丹将于2023年6月5日星期一上午8点开始举行现场电话会议。ET以审查2期ROSE 2临床试验的完整数据。与会者可以在此处注册参加电话会议。虽然不是必需的,但建议参与者在预定开始前十分钟加入呼叫。
电话会议的现场网络直播也将在公司网站投资者和新闻部分的“活动和演示”下进行,网址为:
关于奥昔单抗
ObicetRapib是新一代口服低剂量CETP抑制剂,新阿姆斯特丹正在开发该药,以潜在地克服目前降低低密度脂蛋白治疗的局限性。该公司认为,如果获得批准,obicetRapib有可能成为一种每日一次的口服CETP抑制剂,用于降低低密度脂蛋白-C。在该公司的2b期ROSE试验中,在服用高强度他汀类药物的基础上,10毫克剂量的obicetRapib显示低密度脂蛋白-C比基线降低了51%,而在该公司的第二阶段ROSE 2试验中,10毫克剂量的obicetRapib和10毫克剂量的ezetimibe的组合显示低密度脂蛋白-C比基线降低了63%。在该公司的所有三个第二阶段试验--郁金香、ROSE和SEA中,评估ObicetRapib是单一疗法还是联合疗法,该公司观察到统计上显著的降低低密度脂蛋白活性,并伴有一般中等的副作用,没有与药物相关的、与治疗相关的严重不良事件。到目前为止,在纽阿姆斯特丹的临床试验中,ObicetRapib已经在600多名血脂水平低或高的患者中表现出了很强的耐受性。该公司正在百老汇和布鲁克林进行两个3期关键试验,以评估ObicetRapib作为最大耐受性降脂疗法的单一疗法,潜在地增强高风险心血管疾病患者的低密度脂蛋白的降低。该公司于2022年1月开始在百老汇招收病人,2022年7月在布鲁克林招收病人,并于2023年4月提前完成了在布鲁克林的招生工作。该公司还于2022年3月开始了第三阶段VERVE CVOT,旨在评估ObicetRapib减少MACE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管重建术。
关于新阿姆斯特丹
新阿姆斯特丹(纳斯达克代码:NAMS)是一家临床阶段的生物制药公司,其使命是改善患有代谢性疾病的人群的患者护理,这些人群目前批准的治疗方法尚未获得足够的成功或良好的耐受性。新阿姆斯特丹正在研究口服、低剂量、每天一次的CETP抑制剂obicetRapib,将其作为高危心血管疾病(CVD)患者最大耐受性他汀类药物的首选降低低密度脂蛋白胆固醇疗法的辅助疗法。新阿姆斯特丹的ROSE 2b期试验(在2021年AHA科学会议上公布)的结果包括观察到,在接受高强度他汀类药物治疗的患者中,接受obicetraib 10 mg的患者的低密度脂蛋白-C的中位数下降了51%(而服用安慰剂的患者下降了7%)。此外,新阿姆斯特丹ROSE2试验评估10毫克obicetRapib和10 mg ezetimibe的组合结果显示,在接受高强度他汀类药物治疗的患者中,低密度脂蛋白-C水平比基线降低了63%(而服用安慰剂的患者降低了6%)。总部设在荷兰的新阿姆斯特丹最近完成了与弗雷泽生命科学收购公司(“FLAC”)的业务合并,FLAC是一家由弗雷泽医疗伙伴公司的一家附属公司赞助的特殊目的收购公司。在扣除交易费用之前,这笔交易的收益约为3.28亿美元。2022年6月,新阿姆斯特丹与Menarini Group签订了一项独家许可协议,将obicetRapib在欧洲商业化,同时保留在世界其他地区商业化obicetRapib的所有权利(如果获得批准),以及开发某些形式的obicetRapib治疗阿尔茨海默病等其他疾病的权利。有关更多信息,请访问:。
前瞻性陈述
本文件中包含的非历史事实的某些陈述是为了1995年美国私人证券诉讼改革法中的安全港条款的目的而作出的前瞻性陈述。前瞻性陈述通常伴随着诸如“相信”、“将会”、“继续”、“预期”、“打算”、“预期”、“预测”、“潜在”、“寻求”、“目标”等词语,以及预测或表明未来事件或趋势的类似表达,或者不是对历史事件的陈述。这些前瞻性陈述包括但不限于有关公司的业务和战略计划、公司的临床试验和招募患者的时间(包括3期试验的开始)、公布数据的时间和论坛以及监管部门批准的成就和时间的陈述。这些陈述基于各种假设,无论是否在本文件中确定,并基于公司管理层目前的预期,而不是对实际业绩的预测。这些前瞻性陈述仅用于说明目的,不打算也不能作为对事实或可能性的保证、保证、预测或确定性陈述。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都不是本公司所能控制的。这些前瞻性声明会受到大量风险和不确定性的影响,包括国内外商业、市场、金融、政治和法律条件的变化;与公司预测的有关公司财务信息的不确定性有关的风险;与公司候选产品的批准以及预期的监管和业务里程碑的时间安排有关的风险;与潜在客户谈判最终合同安排的能力;候选竞争产品的影响;获得充足材料供应的能力;新冠肺炎的影响;包括俄罗斯和乌克兰冲突在内的全球经济和政治状况;竞争对公司未来业务的影响;以及该公司向美国证券交易委员会提交的公开文件中描述的那些因素。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,特别是与监管审查和对其候选产品的潜在批准有关的不确定性;与公司将候选产品商业化的努力相关的风险;公司以有利条件谈判并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;与知识产权相关的索赔;公司吸引和保留合格人员的能力;继续为其候选产品采购原材料的能力。如果这些风险中的任何一个成为现实,或者公司的假设被证明是不正确的,实际结果可能与这些前瞻性陈述中暗示的结果大不相同。可能存在公司目前不知道的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结果与前瞻性陈述中包含的结果不同。此外,前瞻性表述反映了截至本文件发表之日公司对未来事件和观点的预期、计划或预测,其全部内容均参考本文中的警告性表述予以保留。公司预计随后发生的事件和发展可能会导致公司的评估发生变化。这些前瞻性陈述不应被视为代表公司在本通讯日期之后的任何日期的评估。因此,不应过分依赖前瞻性陈述。除法律要求外,公司或其任何关联公司均无义务更新这些前瞻性陈述。
公司联系人
马修·菲利普
电话:1917-882-7512
邮箱:matthew.philippe@newamsterDampharma.com
媒体联系人
代表新阿姆斯特丹的光谱科学
珍妮·戈登
电话:1220-957-7795
邮箱:jgordon@spectrumcerence.com
投资者联系方式
代表新阿姆斯特丹的斯特恩投资者关系
汉娜·德雷谢维奇
电话:1212-362-1200
邮箱:hannah.deresiewicz@sternir.com