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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

新阿姆斯特丹製藥公司將在即將舉行的醫學會議上發佈新的臨床和臨床前數據,重點介紹Obicetrapib對心血管疾病關鍵危險因素的影響
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 --

— 演講包括來自 OCEAN、ROSE 和 ROSE2 2 期臨床試驗的新數據,表明了 obicetrapib 對關鍵脂質和脂蛋白生物標誌物的影響 —

-- 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年第三季度報告HeFH的布魯克林三期試驗和2024年第四季度ASCVD的BROADWAY三期試驗的主要數據——

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.

荷蘭納爾登和邁阿密,2024年5月21日(GLOBE NEWSWIRE)——新阿姆斯特丹製藥公司(納斯達克股票代碼:NAMS 或 “新阿姆斯特丹” 或 “公司”)是一家後期臨床生物製藥公司,爲有心血管疾病(“CVD”)風險的低密度脂蛋白膽固醇(“LDL-C”)患者開發口服非他汀類藥物,適用於低密度脂蛋白膽固醇(“LDL-C”)風險患者療法不夠有效或耐受性不佳,今天宣佈將提供新的臨床和臨床前數據,強調obicetrapib作爲一種新型、口服、低濃度的潛力歐洲動脈粥樣硬化協會 (EAS) 92 的高膽固醇血癥劑量療法 國會和全國脂質協會(NLA)2024年科學會議,分別於5月26日至29日在法國里昂和5月30日至6月2日在內華達州拉斯維加斯舉行。

Presentation details are as follows:

演示詳情如下:

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

是 92 國會,法國里昂,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

標題:Obicetrapib 治療可增加 OCEAN 和 ROSE2 研究中的 Beta1 前高密度脂蛋白和親脂性抗氧化劑
會話名稱:0390-SaAg 會話:HDL 的新技巧
口頭演講日期和時間:歐洲中部時間 2024 年 5 月 27 日星期一下午 2:42 至下午 2:49(美國東部時間上午 8:42 至上午 8:49)
地點:7 號站

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

標題:除了高強度他汀類藥物外,Obicetrapib還顯示出Lp(a)的顯著降低
會話名稱:0601-SaAg 會話:最新發現的脂質
口頭演講日期和時間:歐洲中部時間 2024 年 5 月 28 日星期二下午 2:12 至下午 2:19(美國東部時間上午 8:12 至上午 8:19)
地點:8 號站

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

標題:單獨使用Obicetrapib以及與依澤替米貝聯合使用可通過增強低密度脂蛋白受體介導的VLDL清除率和增加Apoe*3-Leiden.CETP小鼠的淨糞便固醇排泄來降低非高密度脂蛋白膽固醇
會議名稱:0660-SaAg 會議:降脂治療的最新進展
口頭演講日期和時間:歐洲中部時間 2024 年 5 月 28 日星期二 3:17-3:24(美國東部時間上午 9:17 至上午 9:24)
地點:3 號站

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

標題:單獨使用Obicetrapib並與依澤替米貝聯合使用可減輕Apoe*3-Leiden.cetp小鼠的動脈粥樣硬化病變大小和嚴重程度
會議名稱:0660-SaAg 會議:降脂治療的最新進展
口頭演講日期和時間:歐洲中部時間 2024 年 5 月 28 日星期二 3:24-3:31(美國東部時間上午 9:24 至上午 9:31)
地點:3 號站

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

標題:Obicetrapib 不會在脂肪組織中積累:對人類和非人類靈長類動物的研究結果
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 科學會議,內華達州拉斯維加斯,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

標題:除了高強度他汀類藥物外,Obicetrapib還顯示出Lp(a)的顯著降低
摘要/海報編號:128
日期和時間:太平洋時間 2024 年 5 月 31 日星期五下午 2:30 至下午 2:55(美國東部時間下午 5:30 至下午 5:55)
地點:海報大廳監視器 #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

標題:Obicetrapib和依澤替米貝對循環低密度脂蛋白顆粒的協同作用
摘要/海報編號:138
日期和時間:太平洋時間 2024 年 5 月 31 日星期五下午 2:30 至下午 2:55(美國東部時間下午 5:30 至下午 5:55)
地點:22號海報大廳監視器

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

標題:Obicetrapib 不會在脂肪組織中積累:對人類和非人類靈長類動物的研究結果摘要/海報編號:127
日期和時間:太平洋時間 2024 年 5 月 31 日星期五下午 2:30 至下午 2:55(美國東部時間下午 5:30 至下午 5:55)
地點:海報大廳監視器 #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

標題:Obicetrapib 治療可增加 OCEAN 和 ROSE2 研究中的 Beta1 前高密度脂蛋白和親脂性抗氧化劑
摘要/海報編號:140
日期和時間:太平洋時間 2024 年 5 月 31 日星期五下午 2:30 至下午 2:55(美國東部時間下午 5:30 至下午 5:55)
地點:海報大廳監視器 #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

標題:評估他汀類藥物治療的患有或有患ASCVD風險的患者中未滿足的臨床需求和醫療資源使用情況
摘要/海報編號:139
日期和時間:太平洋時間 2024 年 5 月 31 日星期五下午 2:30 至下午 2:55(美國東部時間下午 5:30 至下午 5:55)
地點:海報大廳監視器 #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)

演講題目:單獨使用Obicetrapib和依澤替米貝通過增強低密度脂蛋白受體介導的VLDL清除率和增加糞便固醇淨排泄量來降低非高密度脂蛋白C
摘要/海報編號:141
口頭陳述會議:第五場會議
日期和時間:太平洋時間 2024 年 6 月 1 日星期六上午 11:05 至上午 11:55(美國東部時間下午 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.

關於 Obicetrapib
Obicetrapib是一種新型的口服低劑量CETP抑制劑,新阿姆斯特丹正在開發該抑制劑,旨在克服當前降低低密度脂蛋白療法的侷限性。在該公司評估奧比曲拉匹爲單一療法或聯合療法的每項2期試驗(ROSE2、TULIP、ROSE和OCEAN)中,該公司觀察到具有統計學意義的低密度脂蛋白降低,副作用與安慰劑類似。該公司正在進行兩項三期關鍵試驗,即百老匯和布魯克林,評估奧比曲匹作爲一種單一療法,可用作最大耐受性降脂療法的輔助手段,爲心血管疾病患者提供額外的低密度脂蛋白降低,並評估奧比曲匹和依澤替米貝作爲固定劑量組合的藥物。該公司於2022年1月開始在百老匯、2022年7月在布魯克林、2024年3月在TANDEM招收患者;於2023年4月完成布魯克林和2023年7月百老匯的註冊。該公司還於2022年3月啓動了PREVIAL心血管預後3期試驗,該試驗旨在評估obicetrapib在減少重大心血管不良事件發生方面的潛力,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運重建。新阿姆斯特丹於2024年4月完成了PREVAIL的入組,並隨機抽取了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.

關於新阿姆斯特丹
NewAmsterdam Pharma(納斯達克股票代碼:NAMS)是一家處於後期階段的生物製藥公司,其使命是改善目前批准的療法不足或耐受性不佳的代謝性疾病患者的患者護理。我們力求滿足對安全、耐受性好和便捷的降低密度脂蛋白療法的巨大未滿足的需求。在多項3期研究中,NewAmsterdam正在研究obicetrapib,一種口服、低劑量、每日一次的CETP抑制劑,單獨使用或與依澤替米貝作爲固定劑量聯合療法,可用作他汀類藥物治療的輔助療法,用於低密度脂蛋白C升高的心血管疾病風險患者,現有療法不夠有效或耐受性不佳。

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.

前瞻性陳述
就1995年《美國私人證券訴訟改革法》的安全港條款而言,本文件中包含的某些非歷史事實的陳述是前瞻性陳述。前瞻性陳述通常附有 “相信”、“可能”、“將”、“估計”、“繼續”、“預測”、“打算”、“預期”、“應該”、“將”、“計劃”、“預測”、“潛在”、“看起來”、“尋找”、“未來”、“展望” 等詞語以及預測或表明未來事件或趨勢或不是歷史問題陳述的類似表達。這些前瞻性陳述包括但不限於有關公司業務和戰略計劃、公司的商業機會、公司候選產品的治療和治療潛力、公司的臨床試驗和入院時間、公佈數據的時間和論壇、監管部門批准的實現和時機以及商業化計劃的陳述。這些陳述基於各種假設,無論是否在本文件中提出,也基於公司管理層當前的預期,不是對實際業績的預測。這些前瞻性陳述僅用於說明目的,無意作爲擔保、保證、預測或對事實或概率的明確陳述,也不得將其作爲擔保、保證、預測或最終陳述。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是公司無法控制的。這些前瞻性陳述受許多風險和不確定性的影響,包括國內外業務、市場、財務、政治和法律條件的變化;與公司候選產品的批准以及預期監管和業務里程碑的時機相關的風險,包括潛在的商業化;與潛在客戶談判最終合同安排的能力;競爭產品候選人的影響;獲得充足材料供應的能力;全球經濟和政治條件,包括俄羅斯-烏克蘭和以色列-哈馬斯衝突;競爭對公司未來業務的影響;以及公司向證券交易委員會提交的公開文件中描述的因素。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,尤其是與監管審查和候選產品的潛在批准有關的不確定性;與公司努力將候選產品商業化相關的風險;公司以優惠條件進行談判和達成最終協議的能力(如果有的話);競爭產品候選產品對公司業務的影響;知識產權相關索賠;公司的能力吸引和留住合格的人員;能夠繼續爲其候選產品採購原材料。如果其中任何風險得以實現或公司的假設被證明不正確,則實際結果可能與這些前瞻性陳述所暗示的結果存在重大差異。可能還存在公司目前不知道或公司目前認爲不重要的其他風險,這些風險也可能導致實際業績與前瞻性陳述中包含的結果有所不同。此外,前瞻性陳述反映了截至本文件發佈之日公司對未來事件和觀點的預期、計劃或預測,並參照此處的警示性陳述對其進行了全面限定。公司預計,隨後的事件和事態發展可能會導致公司的評估發生變化。不應將這些前瞻性陳述視爲本通信之日後任何日期的公司評估。因此,不應過分依賴前瞻性陳述。除非法律要求,否則公司及其任何關聯公司均不承擔任何更新這些前瞻性陳述的義務。

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

公司聯繫人
馬修·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

媒體聯繫人
代表新阿姆斯特丹的頻譜科學
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

投資者聯繫人
Stern 投資者關係部代表 NewAmsterdam
漢娜·德雷西維奇
P: 1-212-362-1200
hannah.deresiewicz@sternir.com


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