The Medicines Company Reaches Enrollment Target for ORION-9 Ahead of Schedule
February 20 2018 - 7:00AM
Business Wire
- ORION-9, a Phase III confirmatory
clinical trial in heterozygous familial hypercholesterolemia
patients randomized more than 400 patients in 10 weeks – 14 weeks
ahead of schedule
The Medicines Company (NASDAQ: MDCO) today announced that the
target of 400 patients randomized in the ORION-9 trial has been
exceeded in 10 weeks – considerably ahead of its anticipated
recruitment goal of 24 weeks.
ORION-9 is a double-blind, randomized multi-national Phase III
trial designed to confirm the effectiveness and safety of
inclisiran in heterozygous familial hypercholesterolemia patients.
In the trial, patients are randomized to inclisiran 300 mg or
placebo given subcutaneously on days 1, 90, 270 and 450 – then
followed to the end of the study at 540 days (18 months). ORION-9
is one of four pivotal phase III trials with similar designs to
confirm the safety and effectiveness of inclisiran and potentially
provide key data required for NDA and MAA submission in the United
States and Europe, respectively.
The Company announced completion of enrollments in the first
pivotal Phase III study, ORION-11, ahead of schedule on January 25,
2018.
The third pivotal Phase III study is ORION-10, which is actively
enrolling 1500 ASCVD patients in the United States and Canada, is
expected to complete enrollment during the first half of 2018. The
fourth pivotal Phase III study, ORION-5, in up to 60 patients with
homozygous familial hypercholesterolemia (HoFH) is expected to
begin enrolling patients later in 2018 and to provide data for HoFH
as part of a comprehensive LDL-C lowering program in a planned NDA
and MAA submission. On January 23, 2018, the U.S. Food and Drug
Administration (FDA) granted orphan drug designation for inclisiran
for the treatment of HoFH.
“Completion of enrollment in ORION-9 is another key milestone on
our way to confirming the excellent safety and efficacy data for
inclisiran,” said David Kallend, MB BS, Chief Medical Officer of
The Medicines Company. “We look forward to completing the follow-up
of ORION-9 and the enrollment and follow-up of other pivotal
trials, so that we can review the data in the second half of 2019
as part of the anticipated NDA and MAA submissions. We believe that
the rapid pace of enrollment in ORION-11 and ORION-9, as well as
the quality of data emerging from this and other trials, reflect
the design of the studies, the effective operational support of
excellent clinical sites, and the apparent ease of use of the
protocol and study medication.”
About ORION-9
ORION-9 is a Phase III, placebo-controlled, double-blind,
randomized study of ~400 heterozygous familial hypercholesterolemia
patients with elevated LDL-C levels above 100 mg/dL despite maximum
tolerated doses of LDL-C lowering therapies including statins. The
primary endpoint of the study is LDL-C reduction from baseline to
day 510. The trial also evaluates the safety and tolerability of
inclisiran.
About heterozygous familial hypercholesterolemia
According to the Familial Hypercholesterolemia Foundation,
familial hypercholesterolemia (FH) is an inherited disorder that
leads to aggressive and premature cardiovascular disease. This
includes problems like heart attacks, strokes, and even narrowing
of heart valves. For individuals with FH, although diet and
lifestyle are important, they are not the cause of high LDL. In FH
patients, genetic mutations make the liver incapable of
metabolizing (or removing) excess LDL. The result is very high LDL
levels which can lead to premature cardiovascular disease (CVD).
Heterozygous FH occurs in 1 in 250 people worldwide. In the
United States alone, an estimated 1.3 million people live with FH.
Yet only 10% of them are diagnosed. FH runs in families. If one
parent has FH, each child has a 50% chance of having FH. If left
untreated, men have a 50% rise of having a heart attack by age 50.
Untreated women have a 30% risk by age 60. 1 in 160,000 to 1 in 1
million people have HoFH. For more information go to
https://thefhfoundation.org
About inclisiran
Inclisiran is an investigational GalNAc-conjugated RNA
interference therapeutic which inhibits the synthesis of PCSK9
protein in liver cells, thereby reducing liver cell LDL-receptor
turnover, and lowering plasma LDL-C.
The Medicines Company and Alnylam Pharmaceuticals, Inc. are
collaborating in the advancement of inclisiran pursuant to the
terms of their 2013 agreement. Under the terms of that agreement,
Alnylam completed certain pre-clinical studies and the Phase I
clinical study, with The Medicines Company leading and funding the
development of inclisiran from Phase II forward, as well as
potential commercialization.
About The Medicines Company
The Medicines Company is a biopharmaceutical company driven by
an overriding purpose – to save lives, alleviate suffering and
contribute to the economics of healthcare. The Company’s goal is to
create transformational solutions to address the most pressing
healthcare needs facing patients, physicians and providers in
cardiovascular care. The Company is headquartered
in Parsippany, New Jersey.
Forward-Looking Statements
Statements contained in this press release about The Medicines
Company that are not purely historical, and all other statements
that are not purely historical, may be deemed to be forward-looking
statements for purposes of the safe harbor provisions under The
Private Securities Litigation Reform Act of 1995. Without limiting
the foregoing, the words "believes," "anticipates" "expects" and
“potential” and similar expressions, are intended to identify
forward-looking statements. These forward-looking statements
involve known and unknown risks and uncertainties that may cause
the Company's actual results, levels of activity, performance or
achievements to be materially different from those expressed or
implied by these forward-looking statements. Important factors that
may cause or contribute to such differences include whether
clinical trials for inclisiran will advance on a timely basis, or
at all, or succeed in achieving their specified endpoints; whether
physicians will prescribe and patients will use inclisiran, if it
becomes available; whether the Company will make additional
regulatory submissions for inclisiran on a timely basis, or at all;
whether the Company’s regulatory submissions will receive approvals
from regulatory agencies on a timely basis, or at all; and such
other factors as are set forth in the risk factors detailed in the
Company's Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on November 9, 2017, which are incorporated
herein by reference. The Company specifically disclaims any
obligation to update these forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20180220005568/en/
Investor RelationsThe
Medicines CompanyKrishna Gorti, M.D., 973-290-6122Vice President,
Investor Relationskrishna.gorti@themedco.com
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