-- Presentations include new data from OCEAN, ROSE, and ROSE2 Phase 2 clinical trials, demonstrating obicetrapib’s impact on key lipid and lipoprotein biomarkers --
-- 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 --
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.
Presentation details are as follows:
EAS 92nd Congress, Lyon, France, May 26-29, 2024
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
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
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
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
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
NLA 2024 Scientific Sessions, Las Vegas, Nevada, May 30-June 2, 2024
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
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
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
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
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
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)
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.
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.
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.
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
