– 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主要終點,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指南的聯合治療-建議的低密度脂蛋白目標<55 mg/dL,而接受安慰劑治療的患者的這一比例為0%(p<0.05)-
-新數據顯示,在預測心血管疾病風險的其他血脂和脂蛋白參數方面,如低密度脂蛋白顆粒和脂蛋白(A),有統計上顯著和臨床上有意義的改善。
-觀察到良好的安全性和耐受性-
-精選固定劑量聯合片劑配方;第三階段試驗預計將於2024年第一季度啟動-
-管理層將於上午8:00主持電話會議。美國東部時間2023年6月5日星期一-
荷蘭納爾登和邁阿密,2023年6月3日(環球網)--新阿姆斯特丹製藥公司(納斯達克:NAMS或“新阿姆斯特丹”或“公司”),一家臨床階段的生物製藥公司,為心血管疾病(“CVD”)的高風險患者(“低密度脂蛋白膽固醇”或“低密度脂蛋白膽固醇”)殘留升高的患者開發口服非他汀類藥物,對現有治療方法不夠有效或耐受性不佳的患者,今天宣佈了ROSE2的全部結果,這是一項評估obicetRapib的第二階段臨床試驗,低劑量和每日一次的膽固醇酯轉移蛋白(“CETP”)抑制劑,與依折麥布聯合作為高強度他汀類藥物的輔助治療。這些數據將於今天在2023年全國脂質協會(NLA)科學會議上以口頭報告的形式公佈,並將同時發表在臨床類脂學雜誌。
ROSE2達到了其主要和次要終點,觀察到低密度脂蛋白-C和載脂蛋白B(“ApoB”)在統計上顯著和臨床上有意義的降低。在統計上,脂蛋白(A)(“Lp(A)”)、非高密度脂蛋白膽固醇(“非高密度脂蛋白-C”)以及總和小的低密度脂蛋白顆粒也有顯著改善。此外,觀察到奧比曲布和依折麥布的聯合用藥耐受性良好,安全性與安慰劑相當。有了這些數據,該公司已經選擇了固定劑量聯合片劑的配方,並打算在2024年第一季度將該化合物推進到第三階段試驗。
貝勒醫學院心血管研究主任、貝勒醫學院教授兼臨床試驗首席研究員克裡斯蒂·M·巴蘭廷表示:“2022年ACC專家共識決策路徑建議,低密度脂蛋白膽固醇高於55毫克/分升的極高風險患者需要額外的治療,以最大限度地降低已證實的風險。有了這些新的建議,更多的患者將無法實現指南規定的低密度脂蛋白目標,這表明現有療法的侷限性以及對新選擇的迫切需要。”今天公佈的數據非常令人鼓舞,表明obicetRapib和ezetimibe的組合對多種導致動脈粥樣硬化的脂質參數產生了強有力的影響。我相信觀察到的低密度脂蛋白-C、載脂蛋白B、Lp(A)以及總和小的低密度脂蛋白顆粒的減少可能預示著心血管事件風險的大幅降低,並期待著在第三階段試驗中進一步描述obicetRapib和ezetimibe的組合方案的特徵。
ROSE2數據建立在我們以前的臨床經驗的基礎上,支持obicetRapib成為一種新的護理標準的潛力,與現有的選擇安全地結合在一起,為數百萬需要的非常高風險的患者提供改善的結果。我們對今天宣佈的新的目標實現數據特別感到鼓舞,通過這些數據,我們觀察到,接受obicetRapib和ezetimibe聯合療法治療的患者中,87%達到了指南規定的最激進的<55 mg/dL的低密度脂蛋白-C目標,“紐阿姆斯特丹公司首席執行官邁克爾·戴維森醫學博士說,”我們已經選擇了一種固定劑量的聯合片劑配方,並期待著將其推進到第三階段試驗,目標是在2024年第一季度開始。此外,我們繼續推進我們正在進行的百老匯、布魯克林和勝利者審判按計劃進行。我們認為,除了最大耐受性的他汀類藥物治療外,臨床醫生和患者正在尋求口服治療方案,以降低心血管疾病的風險。如果在我們的第三階段試驗中成功,ObicetRapib 10 mg作為單一療法並以固定劑量與ezetimibe聯合使用,很可能是非常需要的治療解決方案。“
ObicetRapib和Ezetimibe的2期ROSE 2期臨床試驗完整數據
ROSE2(NCT05266586)是一項安慰劑對照、雙盲、隨機的2期臨床試驗,目的是評估在高強度他汀類藥物治療的輔助下,奧比曲布10毫克與依折麥布10毫克聯合使用的有效性、安全性和耐受性。患者隨機接受聯合治療,奧比曲布10毫克或安慰劑,為期12周。共有119名患者在ROSE 2中登記,其中97人進入治療分析。基線時出現空腹低密度脂蛋白膽固醇大於70 mg/dL,甘油三酯小於400 mg/dL的患者,均接受穩定劑量的高強度他汀類藥物治療。
主要終點是與安慰劑相比,在Friedewald計算的低密度脂蛋白-C(LDL-C)從基線到第12周的百分比變化中,obicetRapib加ezetimibe聯合治療組與安慰劑相比。次要療效終點包括與安慰劑相比,ObicetRapib單一療法的低密度脂蛋白-C從基線到第12周的百分比變化,以及與安慰劑相比,obicetRapib+ezetimibe組合的ApoB的百分比變化,以及與安慰劑相比,obicetRapib單一療法的百分比變化。研究終點包括從基線到第12周的Lp(A)、非高密度脂蛋白-C、高密度脂蛋白-C、總和小低密度脂蛋白顆粒的百分比變化,以及與安慰劑相比,在治療結束時,與安慰劑相比,奧貝特拉布加依折麥比組和奧貝拉比單用組的低密度脂蛋白-C水準分別低於100 mg/dL、70 mg/dL和55 mg/dL的患者的比例。
與安慰劑相比,每個終點的LS平均值的p值<0.0001。下表顯示了接受奧位元拉布和依折麥布聯合治療、奧位元拉布單一治療和安慰劑治療的患者與基線相比的中位數百分比變化。
與基線相比的中位數百分比變化 | 安慰劑(n=40) | 奧昔曲布10毫克 (n=26) | 奧比曲布10 鎂+依折麥布10 鎂(n=31) |
Friedewald計算的低密度脂蛋白膽固醇 | -6.4 | -43.5 | -63.4 |
載脂蛋白B | -2.1 | -24.2 | -34.4 |
非高密度脂蛋白膽固醇 | -5.6 | -37.5 | -55.6 |
低密度脂蛋白顆粒總數 | -5.7 | -54.8 | -72.1 |
小顆粒低密度脂蛋白 | -8.3 | -92.7 | -95.4 |
低密度脂蛋白顆粒大小 | -0.5 | 1.5 | 1.8 |
比起安慰劑組(分別為100.00%、93.5%和87.1%,分別為66.7%、16.7%和0.0%),奧比曲布和依折替比聯用組的低密度脂蛋白膽固醇水準低於100、<70和<55 mg/dL的患者顯著增多(p<0.05)。此外,我們觀察到單一治療組和聯合用藥組Lp(A)的中位數分別降低了47.2%和40.2%。
觀察到奧比曲布和依折麥布的聯合治療總體上耐受性良好,安全性與安慰劑相當。不良事件一般為輕度至中度,最常見的不良事件是噁心、尿路感染和頭痛,沒有觀察到與藥物有關的、治療緊急的嚴重不良事件。
紐阿姆斯特丹的首席科學官John Kastelein說:“我們對新的脂質顆粒分析特別感到鼓舞,在這種分析中,我們觀察到服用obicetRapib和ezetimibe的患者的Lp(A)以及總和小的低密度脂蛋白顆粒的減少。”觀察到的Lp(A)水準降低近50%,以及高度致動脈粥樣硬化的小低密度脂蛋白顆粒減少95%具有潛在的臨床意義,因為低密度脂蛋白顆粒被認為是心血管疾病風險最可靠的預測因素之一。總之,這些數據進一步加強了奧位元拉比改變治療格局的潛力。
根據新阿姆斯特丹與梅納裡尼集團的許可協定條款,ROSE2試驗的數據觸發了向新阿姆斯特丹支付的臨床成功里程碑付款,該付款於2023年4月收到。
電話會議資訊
新阿姆斯特丹將於2023年6月5日星期一上午8點開始舉行現場電話會議。ET以審查2期ROSE 2臨床試驗的完整數據。與會者可以在此處註冊參加電話會議。雖然不是必需的,但建議參與者在預定開始前十分鐘加入呼叫。
電話會議的現場網路直播也將在公司網站投資者和新聞部分的“活動和演示”下進行,網址為:
關於奧昔單抗
ObicetRapib是新一代口服低劑量CETP抑制劑,新阿姆斯特丹正在開發該藥,以潛在地克服目前降低低密度脂蛋白治療的侷限性。該公司認為,如果獲得批准,obicetRapib有可能成為一種每日一次的口服CETP抑制劑,用於降低低密度脂蛋白-C。在該公司的2b期ROSE試驗中,在服用高強度他汀類藥物的基礎上,10毫克劑量的obicetRapib顯示低密度脂蛋白-C比基線降低了51%,而在該公司的第二階段ROSE 2試驗中,10毫克劑量的obicetRapib和10毫克劑量的ezetimibe的組合顯示低密度脂蛋白-C比基線降低了63%。在該公司的所有三個第二階段試驗--鬱金香、ROSE和SEA中,評估ObicetRapib是單一療法還是聯合療法,該公司觀察到統計上顯著的降低低密度脂蛋白活性,並伴有一般中等的副作用,沒有與藥物相關的、與治療相關的嚴重不良事件。到目前為止,在紐阿姆斯特丹的臨床試驗中,ObicetRapib已經在600多名血脂水準低或高的患者中表現出了很強的耐受性。該公司正在百老匯和布魯克林進行兩個3期關鍵試驗,以評估ObicetRapib作為最大耐受性降脂療法的單一療法,潛在地增強高風險心血管疾病患者的低密度脂蛋白的降低。該公司於2022年1月開始在百老匯招收病人,2022年7月在布魯克林招收病人,並於2023年4月提前完成了在布魯克林的招生工作。該公司還於2022年3月開始了第三階段VERVE CVOT,旨在評估ObicetRapib減少MACE發生的潛力,包括心血管死亡、非致命性心肌梗塞、非致命性中風和非選擇性冠狀動脈血管重建術。
關於新阿姆斯特丹
新阿姆斯特丹(納斯達克代碼:NAMS)是一家臨床階段的生物製藥公司,其使命是改善患有代謝性疾病的人群的患者護理,這些人群目前批准的治療方法尚未獲得足夠的成功或良好的耐受性。新阿姆斯特丹正在研究口服、低劑量、每天一次的CETP抑制劑obicetRapib,將其作為高危心血管疾病(CVD)患者最大耐受性他汀類藥物的首選降低低密度脂蛋白膽固醇療法的輔助療法。新阿姆斯特丹的ROSE 2b期試驗(在2021年AHA科學會議上公佈)的結果包括觀察到,在接受高強度他汀類藥物治療的患者中,接受obicetraib 10 mg的患者的低密度脂蛋白-C的中位數下降了51%(而服用安慰劑的患者下降了7%)。此外,新阿姆斯特丹ROSE2試驗評估10毫克obicetRapib和10 mg ezetimibe的組合結果顯示,在接受高強度他汀類藥物治療的患者中,低密度脂蛋白-C水準比基線降低了63%(而服用安慰劑的患者降低了6%)。總部設在荷蘭的新阿姆斯特丹最近完成了與弗雷澤生命科學收購公司(“FLAC”)的業務合併,FLAC是一家由弗雷澤醫療夥伴公司的一家附屬公司贊助的特殊目的收購公司。在扣除交易費用之前,這筆交易的收益約為3.28億美元。2022年6月,新阿姆斯特丹與Menarini Group簽訂了一項獨家許可協定,將obicetRapib在歐洲商業化,同時保留在世界其他地區商業化obicetRapib的所有權利(如果獲得批准),以及開發某些形式的obicetRapib治療阿爾茨海默病等其他疾病的權利。有關更多資訊,請訪問:。
前瞻性陳述
本文件中包含的非歷史事實的某些陳述是為了1995年美國私人證券訴訟改革法中的安全港條款的目的而作出的前瞻性陳述。前瞻性陳述通常伴隨著諸如“相信”、“將會”、“繼續”、“預期”、“打算”、“預期”、“預測”、“潛在”、“尋求”、“目標”等詞語,以及預測或表明未來事件或趨勢的類似表達,或者不是對歷史事件的陳述。這些前瞻性陳述包括但不限於有關公司的業務和戰略計劃、公司的臨床試驗和招募患者的時間(包括3期試驗的開始)、公佈數據的時間和論壇以及監管部門批准的成就和時間的陳述。這些陳述基於各種假設,無論是否在本文件中確定,並基於公司管理層目前的預期,而不是對實際業績的預測。這些前瞻性陳述僅用於說明目的,不打算也不能作為對事實或可能性的保證、保證、預測或確定性陳述。實際事件和情況很難或不可能預測,可能與假設不同。許多實際事件和情況都不是本公司所能控制的。這些前瞻性聲明會受到大量風險和不確定性的影響,包括國內外商業、市場、金融、政治和法律條件的變化;與公司預測的有關公司財務資訊的不確定性有關的風險;與公司候選產品的批准以及預期的監管和業務里程碑的時間安排有關的風險;與潛在客戶談判最終合同安排的能力;候選競爭產品的影響;獲得充足材料供應的能力;新冠肺炎的影響;包括俄羅斯和烏克蘭衝突在內的全球經濟和政治狀況;競爭對公司未來業務的影響;以及該公司向美國證券交易委員會提交的公開檔案中描述的那些因素。與公司業務相關的其他風險包括但不限於:公司正在進行的臨床試驗結果的不確定性,特別是與監管審查和對其候選產品的潛在批准有關的不確定性;與公司將候選產品商業化的努力相關的風險;公司以有利條件談判並達成最終協定的能力(如果有的話);競爭產品候選產品對公司業務的影響;與知識產權相關的索賠;公司吸引和保留合格人員的能力;繼續為其候選產品採購原材料的能力。如果這些風險中的任何一個成為現實,或者公司的假設被證明是不正確的,實際結果可能與這些前瞻性陳述中暗示的結果大不相同。可能存在公司目前不知道的或公司目前認為不重要的其他風險,這些風險也可能導致實際結果與前瞻性陳述中包含的結果不同。此外,前瞻性表述反映了截至本文件發表之日公司對未來事件和觀點的預期、計劃或預測,其全部內容均參考本文中的警告性表述予以保留。公司預計隨後發生的事件和發展可能會導致公司的評估發生變化。這些前瞻性陳述不應被視為代表公司在本通訊日期之後的任何日期的評估。因此,不應過分依賴前瞻性陳述。除法律要求外,公司或其任何關聯公司均無義務更新這些前瞻性陳述。
公司聯繫人
馬修·菲利普
電話:1917-882-7512
郵箱:matthew.philippe@newamsterDampharma.com
媒體聯繫人
代表新阿姆斯特丹的光譜科學
珍妮·戈登
電話:1220-957-7795
郵箱:jgordon@spectrumcerence.com
投資者聯繫方式
代表新阿姆斯特丹的斯特恩投資者關係
漢娜·德雷謝維奇
電話:1212-362-1200
郵箱:hannah.deresiewicz@sternir.com