NewAmsterdam Pharma Highlights 2024 Achievements and Outlines 2025 Strategic Priorities
NewAmsterdam Pharma (NAMS) provided updates on its obicetrapib clinical development program and 2025 strategic priorities. The company reported positive topline results from three Phase 3 trials in 2024: BROADWAY showed 33% LDL-C reduction and 21% MACE reduction; TANDEM achieved 49% LDL-C reduction with fixed-dose combination; and BROOKLYN demonstrated 36% LDL-C reduction.
The company completed enrollment of over 9,500 patients in the PREVAIL cardiovascular outcomes trial. Additional data from these trials will be presented throughout 2025, supporting global regulatory filings including EMA submission in 2H25. The Phase 2 VINCENT trial, exploring obicetrapib's effect on Lp(a), is expected to report data in 2H25.
NewAmsterdam ended 2024 with an unaudited cash balance of $835 million following an oversubscribed public offering. The company secured patent protection for obicetrapib until July 2043 and is focusing on commercial readiness with manufacturing capacity establishment.
NewAmsterdam Pharma (NAMS) ha fornito aggiornamenti sul suo programma di sviluppo clinico di obicetrapib e sulle priorità strategiche per il 2025. L'azienda ha riportato risultati complessivi positivi da tre studi di Fase 3 nel 2024: BROADWAY ha mostrato una riduzione del 33% del LDL-C e una riduzione del 21% degli eventi avversi cardiovascolari maggiori (MACE); TANDEM ha raggiunto una riduzione del 49% del LDL-C con una combinazione a dose fissa; e BROOKLYN ha dimostrato una riduzione del 36% del LDL-C.
L'azienda ha completato l'arruolamento di oltre 9.500 pazienti nello studio di esito cardiovascolare PREVAIL. Ulteriori dati provenienti da questi studi verranno presentati durante il 2025, a supporto delle domande di registrazione a livello globale, inclusa la presentazione all'EMA nella seconda metà del 25. Si prevede che lo studio di Fase 2 VINCENT, che esplora l'effetto di obicetrapib su Lp(a), riporti dati nella seconda metà del 25.
NewAmsterdam ha chiuso il 2024 con un saldo di cassa non verificato di 835 milioni di dollari dopo un'offerta pubblica sovrascritta. L'azienda ha ottenuto la protezione brevettuale per obicetrapib fino a luglio 2043 e si sta concentrando sulla prontezza commerciale attraverso l'istituzione della capacità produttiva.
NewAmsterdam Pharma (NAMS) proporcionó actualizaciones sobre su programa de desarrollo clínico de obicetrapib y las prioridades estratégicas para 2025. La compañía informó resultados positivos en términos generales de tres ensayos de Fase 3 en 2024: BROADWAY mostró una reducción del 33% en LDL-C y una reducción del 21% en eventos adversos cardiovasculares mayores (MACE); TANDEM logró una reducción del 49% en LDL-C con una combinación a dosis fija; y BROOKLYN demostró una reducción del 36% en LDL-C.
La compañía completó la inscripción de más de 9,500 pacientes en el ensayo de resultados cardiovasculares PREVAIL. Se presentarán datos adicionales de estos ensayos a lo largo de 2025, respaldando las solicitudes regulatorias globales, incluida la presentación a la EMA en la segunda mitad de 2025. Se espera que el ensayo de Fase 2 VINCENT, que explora el efecto del obicetrapib en Lp(a), presente datos en la segunda mitad de 2025.
NewAmsterdam terminó 2024 con un saldo en efectivo no auditado de $835 millones tras una oferta pública sobredimensionada. La compañía aseguró la protección de patente para obicetrapib hasta julio de 2043 y se está enfocando en la preparación comercial con el establecimiento de capacidad de fabricación.
뉴암스테르담 제약(NAMS)은 오비세트라피브 임상 개발 프로그램과 2025년 전략적 우선순위에 대한 업데이트를 제공했습니다. 회사는 2024년 3개의 3상 시험에서 긍정적인 최상위 결과를 보고했습니다: BROADWAY는 LDL-C 33% 감소와 MACE 21% 감소를 보여주었고; TANDEM은 고정 용량 조합으로 LDL-C 49% 감소를 달성하였으며; BROOKLYN은 LDL-C 36% 감소를 입증했습니다.
회사는 PREVAIL 심혈관 결과 시험에서 9,500명 이상의 환자 등록을 완료했습니다. 이러한 시험에서 나오는 추가 데이터는 2025년 동안 발표될 예정이며, 2025년 하반기 EMA 제출을 포함한 글로벌 규제 제출을 지원할 것입니다. Lp(a)에 대한 오비세트라피브의 효과를 탐구하는 2상 VINCENT 시험은 2025년 하반기에 데이터를 보고할 것으로 예상됩니다.
뉴암스테르담은 공개 판매가 초과 신청된 후 2024년을 8억 3,500만 달러의 비감사 현금 잔액으로 종료했습니다. 회사는 오비세트라피브에 대한 특허 보호를 2043년 7월까지 확보했으며 제조 능력 구축을 통해 상업적 준비를 집중하고 있습니다.
NewAmsterdam Pharma (NAMS) a fourni des mises à jour sur son programme de développement clinique d'obicetrapib et sur ses priorités stratégiques pour 2025. L'entreprise a rapporté des résultats globaux positifs de trois essais de phase 3 en 2024 : BROADWAY a montré une réduction de 33% du LDL-C et une réduction de 21% des événements indésirables cardiovasculaires majeurs (MACE) ; TANDEM a atteint une réduction de 49% du LDL-C avec une combinaison à dose fixe ; et BROOKLYN a démontré une réduction de 36% du LDL-C.
L'entreprise a complété l'inscription de plus de 9 500 patients dans l'essai sur les résultats cardiovasculaires PREVAIL. Des données supplémentaires provenant de ces essais seront présentées tout au long de 2025, soutenant les demandes réglementaires mondiales, y compris la soumission à l'EMA dans la seconde moitié de 2025. L'essai de phase 2 VINCENT, qui explore l'effet d'obicetrapib sur Lp(a), devrait faire rapport de données dans la seconde moitié de 2025.
NewAmsterdam a terminé 2024 avec un solde de trésorerie non audité de 835 millions de dollars après une offre publique sursouscrite. L'entreprise a obtenu la protection par brevet pour obicetrapib jusqu'en juillet 2043 et se concentre sur la préparation commerciale avec l'établissement de capacités de production.
NewAmsterdam Pharma (NAMS) hat Updates zu seinem klinischen Entwicklungsprogramm für Obicetrapib und den strategischen Prioritäten für 2025 bereitgestellt. Das Unternehmen berichtete von positiven Gesamtergebnissen aus drei Phase-3-Studien im Jahr 2024: BROADWAY zeigte eine Reduktion des LDL-C um 33% und eine Reduktion der MACE um 21%; TANDEM erreichte eine Reduktion des LDL-C um 49% mit einer Fixkombination; und BROOKLYN demonstrierte eine Reduktion des LDL-C um 36%.
Das Unternehmen hat die Einschreibung von über 9.500 Patienten in der PREVAIL-Studie zu kardiovaskulären Ergebnissen abgeschlossen. Weitere Daten aus diesen Studien werden im Jahr 2025 präsentiert, um globale regulatorische Einreichungen, einschließlich der Einreichung bei der EMA in der zweiten Jahreshälfte 2025, zu unterstützen. Die Phase-2-Studie VINCENT, die die Wirkung von Obicetrapib auf Lp(a) untersucht, wird voraussichtlich in der zweiten Jahreshälfte 2025 Daten berichten.
NewAmsterdam beendete das Jahr 2024 mit einem nicht geprüften Kassenbestand von 835 Millionen US-Dollar nach einem überzeichneten öffentlichen Angebot. Das Unternehmen sicherte sich Patentsschutz für Obicetrapib bis Juli 2043 und konzentriert sich auf die Marktreife durch den Aufbau von Produktionskapazitäten.
- Positive Phase 3 results across three trials (BROADWAY, TANDEM, BROOKLYN) with significant LDL-C reductions
- 21% reduction in MACE observed in BROADWAY trial
- Strong cash position of $835 million at year-end 2024
- Patent protection secured until July 2043
- Successful enrollment completion of 9,500+ patients in PREVAIL trial
- None.
Insights
The unaudited cash position of
The Phase 3 clinical trial results demonstrate compelling efficacy with LDL-C reductions of
The company's manufacturing scale-up and inventory build-out strategy indicates preparation for substantial commercial demand, while the partnership with Menarini for European commercialization provides additional validation and revenue potential.
The clinical data from multiple Phase 3 trials presents a robust efficacy profile for obicetrapib. The BROADWAY trial's
The initiation of VINCENT studying obicetrapib's effect on Lp(a), both alone and in combination with PCSK9 inhibitors, represents a strategic expansion into addressing multiple cardiovascular risk factors. This could differentiate obicetrapib from other lipid-lowering therapies and expand its potential market reach.
The safety profile being comparable to placebo across multiple trials strengthens the drug's potential as a mainstream therapy for patients intolerant to or inadequately controlled on statins.
The cardiovascular disease market represents a massive opportunity, with millions of patients requiring alternatives to statins. Obicetrapib's oral administration offers a significant advantage over injectable PCSK9 inhibitors, while its efficacy profile positions it competitively against other oral therapies.
The comprehensive development program spanning over 12,250 patients and multiple indications demonstrates NewAmsterdam's strategic approach to market penetration. The fixed-dose combination with ezetimibe particularly targets the growing market segment seeking convenient, multi-mechanism treatments.
The planned global regulatory filings, including EMA submission in 2H25, suggest a well-coordinated commercial strategy. The partnership with Menarini for European markets leverages established distribution networks and local market expertise, potentially accelerating market uptake upon approval.
-- 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
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 were33% and36% , 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, a21% 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 were52% and54% , 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 were36% and39% , 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
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
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 Contact
Matthew Philippe
P: 1-917-882-7512
matthew.philippe@newamsterdampharma.com
Media Contact
Spectrum Science on behalf of NewAmsterdam
Jaryd Leady
P: 1-856-803-7855
jleady@spectrumscience.com
Investor Contact
Precision AQ on behalf of NewAmsterdam
Austin Murtagh
P: 1-212-698-8696
austin.murtagh@precisionaq.com
FAQ
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