NewAmsterdam Pharma to Present New Analysis from the Phase 2 ROSE2 Trial Evaluating Obicetrapib in Combination with Ezetimibe at 2024 American College of Cardiology Congress
25 März 2024 - 1:00PM
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 additional data from the Phase 2 ROSE2 clinical
trial at the 2024 American College of Cardiology Congress (“ACC”)
in Atlanta, Georgia, being held April 6-8. ROSE2 evaluated
obicetrapib in combination with ezetimibe as an adjunct to
high-intensity statin therapy; full results from the trial were
previously presented at the National Lipid Association Scientific
Sessions in June 2023. At ACC, NewAmsterdam will share new data
demonstrating obicetrapib and ezetimibe’s impact on small dense
LDL-C, a robust predictor of residual risk of future cardiovascular
events.
NewAmsterdam recently initiated TANDEM, a pivotal Phase 3
clinical trial to evaluate obicetrapib and ezetimibe FDC
(‘fixed-dose combination”) in adult patients with Heterozygous
Familial Hypercholesterolemia (“HeFH”) and/or Atherosclerotic
Cardiovascular Disease (“ASCVD”) or multiple risk factors for
ASCVD, whose LDL-C is not adequately controlled despite being on
maximally tolerated lipid-modifying therapies.
Details of the presentation are as follows:
Presentation at the 2024 American College of Cardiology
(ACC) Congress:Session Title: 1433:
Prevention and Health Promotion: Lipids 12Session
Date/Time: Sunday, April 7, 2024, 1:15 p.m.
EDTSession Location: Hall B4-5, World Congress
CenterPresentation Title: 211 - Synergistic Effect
of Obicetrapib and Ezetimibe on Circulating LDL
ParticlesLocation: Atlanta, Georgia, U.S.
About ObicetrapibObicetrapib is a novel, oral,
low-dose CETP inhibitor that NewAmsterdam is developing to 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 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, including no
increase in blood pressure or muscle related side effects.
Obicetrapib has demonstrated strong tolerability in more than 800
patients with 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 provide additional
LDL-lowering for CVD patients and TANDEM, to evaluate obicetrapib
and ezetimibe as a FDC. 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.
About NewAmsterdamNewAmsterdam 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 preferred 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 StatementsCertain 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,”
“could,” “plan,” “predict,” “potential,” “position,” “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 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 relating
to the uncertainty of the projected financial information with
respect to the Company; 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, 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; 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 ContactMatthew PhilippeP: 1
917-882-7512matthew.philippe@newamsterdampharma.com
Media ContactSpectrum Science on behalf of
NewAmsterdamJenn GordonP: 1
202-957-7795jgordon@spectrumscience.com
Investor ContactStern Investor Relations on
behalf of NewAmsterdamHannah DeresiewiczP: 1
212-362-1200hannah.deresiewicz@sternir.com
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