-- Achieved primary endpoint of LS mean reduction
in LDL-C on top of maximally tolerated lipid modifying therapies at
week 12 with statistically significant reduction (p<0.0001),
which was sustained at week 52 (p<0.0001) --
-- Obicetrapib lowered LDL-C by 36.3% at
week 12 and by 41.5% at week 52, compared to
placebo --
-- Obicetrapib was well-tolerated; safety results comparable
to placebo--
FLORENCE, Italy, July 29,
2024 /CNW/ -- Menarini Group today
announces positive topline data from the Phase 3 BROOKLYN
clinical trial (NCT05425745) sponsored by NewAmsterdam Pharma
Company N.V. ("NewAmsterdam"), a biopharmaceutical company which
granted the Menarini Group an exclusive license to commercialize
obicetrapib in Europe, either as a
monotherapy or as part of a fixed dose combination with ezetimibe,
for cardiovascular diseases. The phase 3 BROOKLYN clinical trial
(NCT05425745), the first of four studies in NewAmsterdam's pivotal
clinical development program, was designed to evaluate obicetrapib
in adult patients with heterozygous familial hypercholesterolemia
("HeFH"), whose low-density lipoprotein cholesterol
("LDL-C") level is not adequately controlled, despite being on
maximally tolerated lipid-lowering therapy.
The BROOKLYN trial met its
primary endpoint, achieving a LS mean reduction of 36.3% (p <
0.0001) compared to placebo at week 12, which was sustained at 52
weeks with a LS mean LDL-C reduction of 41.5% (p < 0.0001). Over
50% of patients achieved an LDL-C level below 70 mg/dl. The
reductions in other biomarkers, including non-HDL-C, ApoB, and
Lp(a), met statistical significance and were consistent with prior
studies.
In the study, obicetrapib proved to be well-tolerated, with no
increase in blood pressure. Any study drug related treatment
emergent adverse events occurred in 6.8% patients in the placebo
arm versus 4.3% patients in obicetrapib arm and no study drug
related treatment emergent serious events were reported in both
treatment arms. The treatment discontinuation rate for obicetrapib
was 7.6% versus 14.4% for placebo.
"BROOKLYN data has
confirmed obicetrapib's ability to significantly reduce LDL-C in
HeFH patients, a population already on multiple lipid-lowering
therapies. I am incredibly encouraged by these results, which
suggest we may have a new, high-efficacy, oral option for a
difficult-to-treat patient population" said
Stephen Nicholls, M.B.B.S., Ph.D.,
Director, Monash Victorian Heart Institute and Professor of
Cardiology, Monash University and principal investigator of the
entire obicetrapib development program.
"Heterozygous Familial Hypercholesterolemia, or HeFH, affects
1 in 250 people worldwide and leads to increased risk of major
adverse cardiovascular events, including stroke, myocardial
infarction, or death, which often occur at a younger age than in
the general population. While it's widely acknowledged that the
increased risk is driven by elevated levels of LDL-C, many HeFH
patients are unable to attain guideline-recommended LDL-C levels,
despite currently available treatment options," said Katherine
Wilemon Founder and CEO of the Family Heart Foundation. "HeFH
patients are difficult to treat, often requiring multiple therapies
to control their LDL-C levels. We are highly encouraged with these
results and the potential to have another efficacious oral
option."
"Cardiovascular diseases (CVDs) are the leading cause of
death globally, taking an estimated 17.9 million lives each year.
Despite the widespread availability of lipid lowering therapies,
CVD-related deaths have risen and patients remain above LDL-C
targets. Patients and their doctors need additional options. We are
very pleased that BROOKLYN
confirmed the ability of obicetrapib to significantly reduce LDL-C
in a challenging patient population, over a duration of one year.
This represents an important milestone in our commitment to offer
the HeFH community in Europe a
potential first in class, oral CETP-i in the fight against
cardiovascular diseases, a mission of over 30 years for our
company", said Elcin Barker Ergun,
Chief Executive Officer of the Menarini Group.
Design of the Pivotal Phase 3 BROOKLYN Clinical Trial
The 52-week, global, pivotal, Phase 3, randomized, double-blind,
placebo-controlled multicenter study evaluated the efficacy and
safety of 10 mg obicetrapib compared to placebo as an adjunct to
maximally tolerated lipid-lowering therapies in patients with HeFH
whose LDL-C is not adequately controlled. The study was conducted
at sites in North America,
Europe and Africa. A total of 354 patients were
randomized 2:1 to receive 10 mg obicetrapib or placebo dosed as a
once-daily oral treatment, with or without food. The mean baseline
LDL-C for enrolled patients in the obicetrapib arm was 123 mg/dL
despite high intensity statin use reported by approximately 79% of
patients during screening. Females comprised approximately 53% of
the study population and the median age of participants at baseline
was 57 years.
The primary objective was to evaluate the effect of obicetrapib
on LDL-C levels. Secondary objectives include evaluating the effect
of obicetrapib on non-high-density lipoprotein cholesterol
("non-HDL-C"), apolipoprotein B ("ApoB"), and lipoprotein (a). The
trial also evaluated the safety and tolerability profile of
obicetrapib.
Obicetrapib's Global Pivotal Phase 3 Program
Obicetrapib global, pivotal Phase 3 clinical development
program consists of four studies in over 12,250 patients, three for
obicetrapib monotherapy and one for a fixed-dose combination
("FDC") with ezetimibe:
- BROOKLYN evaluated
obicetrapib in patients with HeFH, whose LDL-C is not adequately
controlled, despite being on maximally tolerated lipid-lowering
therapy (NCT05425745). Topline data reported in the third quarter
of 2024.
- BROADWAY is evaluating obicetrapib in adult patients
with established ASCVD and/or HeFH, whose LDL-C is not adequately
controlled, despite being on maximally tolerated lipid-lowering
therapy (NCT05142722). Study enrollment of over 2,500 patients was
completed in July 2023
and topline data are expected to be reported in the fourth
quarter of 2024.
- TANDEM is evaluating obicetrapib as part of a FDC tablet
with ezetimibe, a non-statin oral LDL-lowering therapy, in 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 (NCT06005597).
Study enrollment of over 400 patients was completed in July 2024 and topline data are expected to be
reported in the first quarter of 2025.
- PREVAIL is a cardiovascular outcomes trial ("CVOT")
evaluating obicetrapib in patients with a history of ASCVD, whose
LDL-C is not adequately controlled, despite being on maximally
tolerated lipid-lowering therapy (NCT05202509). Study enrollment of
over 9,500 patients was completed in April
2024.
About Obicetrapib
Obicetrapib is a novel, under development, oral, low-dose CETP
inhibitor to overcome the limitations of current LDL-lowering
treatments. In each of the Phase 2 trials, ROSE, ROSE2, TULIP, and
OCEAN, evaluating obicetrapib as monotherapy or in combination
therapy, it was observed a statistically significant LDL-lowering
combined with a good tolerability. Obicetrapib is being
investigated in other three Phase 3 pivotal trials, BROADWAY and
PREVAIL, evaluating obicetrapib as a monotherapy used as an adjunct
to maximally tolerated lipid-lowering therapies to provide
additional LDL-lowering and cardiovascular protection for
cardiovascular disease ("CVD") patients and TANDEM, evaluating
obicetrapib and ezetimibe as a fixed-dose combination. Patients
enrollment in BROADWAY began in January
2022, and in TANDEM in March
2024; enrollment of BROADWAY was completed in July 2023, and TANDEM in July 2024. 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, commenced in March
2022 and the enrollment was completed in April 2024 with over 9,500 patients
randomized.
About The Menarini Group
The Menarini Group is a leading international pharmaceutical and
diagnostics company, with a turnover of $4.7
billion and over 17,000 employees. Menarini is focused on
therapeutic areas of high unmet needs with products for cardiology,
oncology, pneumology, gastroenterology, infectious diseases,
diabetology, inflammation, and analgesia. With 18 production sites
and 9 Research and Development centers, Menarini's products are
available in 140 countries worldwide. For further information,
please visit www.menarini.com.
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.
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