-- Achieved Primary Endpoint with Statistically Significant 45.8% Median Reduction in LDL-C (p < 0.0001) in patients treated with 10mg obicetrapib--
-- 29.7% Median Reduction in Apo B and 37.0% Median Reduction in non-HDL-C from Baseline (p < 0.0001) in patients treated with 10mg obicetrapib --
-- Favorable Safety and Tolerability Observed --
-- Data Enable PMDA Regulatory Path Aligned with Rest of World; Plan to Leverage Data from Ongoing Phase 3 BROOKLYN, BROADWAY and PREVAIL Trials to Support Potential Approval in Japan --
-- Management to Host Conference Call Today at 8:00 a.m. E.T. --
NAARDEN, the Netherlands and MIAMI, June 05, 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 statistically significant and clinically meaningful topline results from the Phase 2b dose-finding trial of obicetrapib, the company's oral, low-dose and once-daily cholesteryl ester transfer protein ("CETP") inhibitor, as an adjunct to stable statin therapy in Japanese patients with dyslipidemia. Based on the results observed, NewAmsterdam plans to leverage data from the ongoing Phase 3 BROOKLYN, BROADWAY and PREVAIL clinical trials, if supportive, to pursue regulatory approval in Japan.
"Despite the availability of statins, elevated levels of LDL-C continue to pose a significant public health burden. A considerable number of patients fail to achieve sufficient LDL-C lowering on existing treatment options or are unable to access these therapies due to high costs," said Mariko Harada-Shiba, M.D., Ph.D., Director at the Department of Molecular Innovation in Lipidology at Osaka Medical and Pharmaceutical University. "There are currently millions of people living with atherosclerotic cardiovascular disease ("ASCVD") or heterozygous familial hypercholesterolemia ("HeFH") in Japan. Like in other geographies, there is a significant unmet need for an oral therapy that can help many more patients achieve target LDL-C goals. Based on the data reported today, I believe incorporating obicetrapib, if approved, alongside statin therapy may emerge as a promising treatment approach, and I look forward to partnering with the NewAmsterdam team to advance obicetrapib's development globally."
Topline Data from the Phase 2b Japan Trial
"After announcing positive data from our ROSE2 trial at the National Lipid Association ("NLA") Scientific Sessions this weekend, we are excited to report strong clinical results from the Phase 2b trial assessing obicetrapib in Japanese patients," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. "We are particularly encouraged by the consistency of these results with data observed across our clinical program to-date, which reinforces our belief in obicetrapib as a potentially paradigm-changing medicine. Importantly, we believe these data enable us to pursue a regulatory strategy in Japan aligned with our efforts in the rest of the world and look forward to seeking global approval for obicetrapib, if the data from our three pivotal Phase 3 trials, BROOKLYN, BROADWAY and PREVAIL, is positive. With our operational expertise and a strong partner to support obicetrapib commercialization in Europe, if approved, we believe we are well positioned to significantly improve patient outcomes and to potentially transform healthcare for millions of people who are living with cardiometabolic diseases."
The Phase 2b trial was a placebo-controlled, double-blind, randomized, dose-finding trial to evaluate the efficacy, safety and tolerability of obicetrapib as an adjunct to stable statin therapy in Japanese patients. The trial enrolled 102 adult participants, who were randomized 1:1:1:1 to receive obicetrapib 2.5mg, 5mg, 10mg or placebo for a 56-day treatment period.
Patients treated with obicetrapib 2.5mg, 5mg, or 10mg, achieved a median reduction in LDL-C of 24.8%, 31.9%, and 45.8%, respectively, as compared to patients treated with placebo, who achieved a median reduction in LDL-C of 0.9%. In addition, patients treated with obicetrapib 10mg achieved a median reduction in apolipoprotein B ("Apo B") of 29.7%, compared to a 1.2% reduction in patients treated with placebo, and a median reduction in non-high-density lipoprotein cholesterol ("non-HDL-C") of 37.0%, as compared to a 0.4% reduction in patients treated with placebo. The p-value for each endpoint compared to placebo was <0.0001. Overall, the different dosages of obicetrapib were observed to be well-tolerated, with a safety profile comparable to placebo.
NewAmsterdam anticipates sharing full data from this Phase 2b clinical trial in a forthcoming publication or in a presentation at an upcoming medical meeting.
Conference Call and Webcast
NewAmsterdam will host a conference call today at 8:00 a.m. ET to review these data, as well as the full data from the Phase 2 ROSE2 clinical trial, which were presented on Saturday. To access the live conference call, please register 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 four of the Company's Phase 2 trials, ROSE2, 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," "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 clinical trials and the timing for enrolling patients, 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
--在服用10毫克Obicetraib的患者中,达到了主要终点,低密度脂蛋白-C的中位数降低了45.8%(p<0.0001)。
--服用10毫克Obicetraib的患者的载脂蛋白B和非高密度脂蛋白胆固醇的中位数较基线分别降低29.7%和37.0%(p<0.0001)。
--观察到良好的安全性和耐受性--
--数据使PMDA监管路径与世界其他地区保持一致;计划利用正在进行的布鲁克林、百老汇和普罗韦试验第三阶段的数据,支持日本的潜在批准--
-管理层将于今天上午8:00主持电话会议。外星人--
荷兰纳尔登和迈阿密,2023年6月5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”)是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,今天宣布了具有统计学意义和临床意义的topline结果。低剂量和每日一次的胆固醇酯转移蛋白(CETP)抑制剂,作为日本血脂异常患者稳定他汀类药物治疗的辅助药物。根据观察到的结果,新阿姆斯特丹计划利用正在进行的布鲁克林、百老汇和胜利者临床试验的数据,如果支持的话,寻求日本的监管批准。
大阪医科大学脂类分子创新教研室的原田真纪子博士说:“尽管有他汀类药物可用,但高水平的低密度脂蛋白胆固醇仍然对公众健康构成巨大的负担。相当多的患者未能在现有的治疗方案中实现充分的低密度脂蛋白胆固醇降低,或者由于高昂的费用而无法获得这些疗法。”目前,日本有数百万人患有动脉粥样硬化性心血管疾病(ASCVD)或杂合性家族性高胆固醇血症(HeFH)。与其他地区一样,对口服疗法的巨大需求尚未得到满足,这种疗法可以帮助更多患者实现目标低密度脂蛋白-C目标。根据今天报道的数据,我相信,如果获得批准,将ObicetRapib与他汀类药物结合使用可能会成为一种有前途的治疗方法,我期待着与纽阿姆斯特丹团队合作,推动ObicetRapib在全球的发展。
日本2b期试验的背线数据
纽阿姆斯特丹公司首席执行官迈克尔·戴维森说:“在本周末在美国国家脂质协会(”NLA“)科学会议上宣布了我们ROSE2试验的积极数据后,我们很高兴地报告了在日本患者中评估obicetRapib的2b期试验的强劲临床结果。我们尤其感到鼓舞的是,这些结果与我们临床计划迄今观察到的数据保持一致,这加强了我们对ObicetRapib作为一种潜在改变范式的药物的信念。重要的是,我们相信这些数据使我们能够在日本推行与我们在世界其他地区的努力相一致的监管战略,并期待着寻求全球批准obicetRapib,如果我们的三个关键阶段试验--布鲁克林、百老汇和盛行--的数据是积极的。凭借我们的运营专业知识和一个强大的合作伙伴来支持obicetRapib在欧洲的商业化,如果获得批准,我们相信我们处于有利地位,可以显著改善患者的结果,并有可能改变数百万患有心脏代谢疾病的人的医疗保健。“
2b期试验是一项安慰剂对照、双盲、随机、剂量发现试验,旨在评估奥比特拉布作为稳定的他汀类药物辅助治疗在日本患者中的有效性、安全性和耐受性。这项试验招募了102名成年参与者,他们以1:1:1:1的随机比例接受奥比曲布2.5 mg、5 mg、10 mg或安慰剂治疗,疗程为56天。
与服用安慰剂的患者相比,服用奥比曲布2.5 mg、5 mg或10 mg的患者的低密度脂蛋白-C的中位数分别降低了24.8%、31.9%和45.8%,后者的低密度脂蛋白-C的中位数降低了0.9%。此外,服用奥比曲布10毫克的患者载脂蛋白B(Apo B)的中位数降低了29.7%,而服用安慰剂的患者降低了1.2%,非高密度脂蛋白胆固醇(非高密度脂蛋白胆固醇)的中位数降低了37.0%,而服用安慰剂的患者降低了0.4%。与安慰剂相比,每个终点的p值<0.0001。总体而言,观察到不同剂量的奥比曲布耐受性良好,安全性与安慰剂相当。
新阿姆斯特丹预计将在即将出版的出版物或即将召开的医学会议上的报告中分享这项2b期临床试验的全部数据。
电话会议和网络广播
新阿姆斯特丹将于今天上午8点举行电话会议。ET审查这些数据,以及周六公布的2期ROSE 2临床试验的完整数据。要收听现场直播的电话会议,请在此处注册。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%。在该公司的所有四个第二阶段试验中,即ROSE2、Tulip、ROSE和Ocean,将obicetRapib作为单一疗法或联合疗法进行评估,该公司观察到统计上显著的降低低密度脂蛋白的活性,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“相信”、“可能”、“将会”、“估计”、“继续”、“预期”、“打算”、“预期”、“应该”、“将会”、“计划”、“预测”、“潜在”、“似乎”、“寻求”、“未来”、“展望”等词汇,以及预测或表明未来事件或趋势或不是历史事件的类似表述。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机、宣布数据的时机和论坛以及监管批准的成就和时机的陈述。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不承担更新这些前瞻性陈述的义务。
公司联系人
马修·菲利普
电话:1-917-882-7512
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:1-202-957-7795
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:1-212-362-1200
邮箱:hannah.deresiewicz@sternir.com