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 completion of patient
enrollment in the pivotal Phase 3 BROADWAY clinical trial
evaluating obicetrapib in adult patients with heterozygous familial
hypercholesterolemia (“HeFH”) and/or established atherosclerotic
cardiovascular disease (“ASCVD”), whose LDL-C is not adequately
controlled, despite being on maximally tolerated lipid-lowering
therapy. The target enrollment of 2,400 subjects was exceeded due
to strong interest from patients and physicians globally.
NewAmsterdam expects over 2,500 patients to be randomized following
the completion of ongoing patient screening and remains on track to
report topline data in the second half of 2024.
“We are pleased to announce the over enrollment in the Phase 3
BROADWAY trial, highlighting the robust demand for a convenient
oral therapy and marking an important next step toward our goal of
delivering obicetrapib to the millions of patients who, despite
being treated with maximally tolerated lipid-lowering therapy,
still do not reach their risk-based LDL-C goals,” said Michael
Davidson, M.D., Chief Executive Officer of NewAmsterdam. “Emerging
clinical data continue to demonstrate the potential for our CETP
inhibitor to solve a substantial unmet need in dyslipidemia by
reducing LDL-C and impacting a number of other lipid and
lipoprotein parameters predictive of cardiovascular disease
risk.”
The double-blind, placebo-controlled Phase 3 BROADWAY trial is
expected to randomize over 2,500 patients with HeFH and/or ASCVD
across eight countries including the United States, Netherlands,
Japan and China. The mean baseline LDL-C for enrolled patients is
approximately 100 mg/dL despite high intensity statin use reported
by greater than 60% of patients during screening. Females comprise
approximately 30% of the study population and the median age of
participants is approximately 66 years. Patients were randomized to
receive placebo or 10 mg obicetrapib, on top of maximally tolerated
lipid-lowering therapy, dosed as a once-daily oral treatment with
or without food for 52 weeks. The primary objective is to evaluate
the effect of obicetrapib on LDL-C levels at day 84. Secondary
objectives include evaluating the effect of obicetrapib on
apolipoprotein B, lipoprotein(a), high density lipoprotein
cholesterol (“HDL-C”), non-HDL-C, total cholesterol and
triglycerides at day 84, and on LDL-C levels at days 180 and 365.
The trial is also evaluating the safety and tolerability of
obicetrapib.
“HeFH and ASCVD can be devastating diseases which, if
inadequately addressed, can result in myocardial infarction,
cerebral infarction, or cardiovascular death,” said John Kastelein,
M.D., Ph.D., FESC, Chief Scientific Officer of NewAmsterdam. “It
has become increasingly clear that lower levels of LDL-C are
directly correlated with a reduced risk for major adverse
cardiovascular events. With obicetrapib, we aim to deliver LDL-C
reductions that are substantially better than currently available
non-statin oral therapies, in a convenient, tolerable formulation.
We are pleased to have both BROADWAY and BROOKLYN, the two pivotal
Phase 3 trials necessary to support a potential LDL regulatory
filing, fully enrolled and look forward to reporting data from both
studies in the second half of 2024.”
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 all five of
the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, OCEAN, and
TA-8995-203, 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 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 in April 2023 and
BROADWAY in July 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 NewAmsterdamNewAmsterdam (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
patients. Based in the Netherlands, NewAmsterdam recently completed
a business combination with Frazier Lifesciences Acquisition
Corporation, a special purpose acquisition company sponsored by an
affiliate of Frazier Healthcare Partners.
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,”
“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
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 SEC. 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 Philippematthew.philippe@newamsterdampharma.com
Media Contact
Spectrum Science on behalf of NewAmsterdamJenn GordonP:
1-202-957-7795jgordon@spectrumscience.com
Investor Contact
Stern Investor Relations on behalf of NewAmsterdamHannah
DeresiewiczP:
1-212-362-1200hannah.deresiewicz@sternir.com
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