— Compelling efficacy and safety data from
ORION-1 interim analysis confirm results up to Day 90 from PCSK9si
Phase 1 study and significantly exceed ORION-1 study objectives
—
— PCSK9si again demonstrated significant and
durable LDL-C reduction-with even greater statistical
robustness-reaffirming triannual and potentially biannual dosing
regimen —
— PCSK9si continues to demonstrate high
standards of safety and tolerability—
— Data from ORION-1 affirm PCSK9si’s
highly-competitive profile —
— Detailed results, including Day 90 follow-up
for all 501 patients and top-line data from preliminary analysis of
Day 180 follow-up for up to 200 patients, will be presented in
Late-Breaking Clinical Trial Session at American Heart Association
meeting on November 15, 2016 —
The Medicines Company (NASDAQ:MDCO) today announced top-line
results from the interim analysis with Day 90 follow-up for all 501
patients enrolled in the ongoing ORION-1 study of PCSK9si, its
investigational first-in-class PCSK9 synthesis inhibitor. Data from
the interim analysis confirm the significant and durable LDL-C
reduction demonstrated up to Day 90 in the preceding Phase 1 study.
PCSK9si was well tolerated and no material safety issue was
observed in the Day 90 interim analysis of unblinded safety data,
including no investigational drug-related elevation of liver
enzymes, neuropathy or change in renal function. Injection site
reactions were infrequent, mild or moderate, and short-lived.
“We are highly encouraged by the strength and consistency of the
Day 90 efficacy and safety data from ORION-1, which build
significantly on the promise generated by the preceding Phase 1
study of PCSK9si,” said Clive Meanwell, M.D., Ph.D., Chief
Executive Officer of The Medicines Company. “These compelling
interim data affirm PCSK9si’s highly-competitive profile and
validate PCSK9si’s game-changing potential. We look forward to
presenting results from the ORION-1 study, including Day 180
follow-up for up to 200 patients, at the AHA meeting on November
15, 2016.”
David Kallend, MBBS, Vice President and Global Medical Director
at The Medicines Company, added, “Based on the results from our
ORION-1 Day 90 interim analysis, PCSK9si has again demonstrated
robust and durable knockdown of LDL-C, as well as impressive safety
and tolerability. These results validate a triannual, and
potentially biannual, low volume subcutaneous dose regimen, which
we believe represents a compelling, highly-differentiated approach
for treating patients with hypercholesterolemia.”
“The thoughtful and robust design of the ORION-1 study has
delivered highly impressive interim data,” said John J.P.
Kastelein, M.D., Ph.D., Professor of Medicine and Chairman of the
Department of Vascular Medicine at the Academic Medical Center of
the University of Amsterdam. “The potential for management of
hypercholesterolemia with two or three low volume injections per
year could open a new, transformative and affordable pathway for
patients and physicians in the treatment of atherosclerotic
cardiovascular disease.”
The interim analysis of Day 90 follow-up for all 501 patients,
as well as top-line data from Day 180 follow-up for up to 200
patients, will be presented in a Late-Breaking Clinical Trials
session at the AHA Scientific Sessions 2016 on November 15,
2016 in New Orleans. In order to protect the scientific
integrity of the ongoing ORION-1 study, the Company does not expect
to provide additional information or make further public statements
regarding the results of the study in advance of the ORION-1
presentation at the AHA Scientific Sessions. The Company
anticipates that data from Day 180 follow-up in all 501 patients
will be completed, analyzed and top-line results disclosed before
the end of 2016.
About ORION-1
ORION-1 is a placebo-controlled, double-blind, randomized,
dose-finding Phase 2 trial of single or multiple subcutaneous
injections of PCSK9si in a total of 501 patients with
atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk
equivalents (e.g., diabetes and
familial hypercholesterolemia) and elevated LDL-C despite maximum
tolerated doses of LDL-C lowering therapies. The trial compares the
effect of different doses of PCSK9si and evaluates the potential
for dosing no more than two, three or four times per year.
About PCSK9si (also known as ALN-PCSsc)
PCSK9si is an investigational proprotein convertase
subtilisin/kexin type 9 (PCSK9) synthesis inhibitor, which acts via
RNA interference, being developed for the treatment of
hypercholesterolemia. PCSK9 is a genetically-validated protein
regulator of LDL receptor metabolism. In contrast to anti-PCSK9
monoclonal antibodies (MAbs) that bind to PCSK9 in blood, PCSK9si
is a first-in-class investigational medicine that acts by
inhibiting PCSK9 synthesis in the liver.
In a previous, single-ascending dose study, PCSK9si was
associated with maximal PCSK9 knockdown of 88.7 percent with mean
maximum knockdown of up to 82.3 ± 2.0 percent and maximal LDL-C
reduction of 78.1 percent with mean maximum lowering of up to 59.3
± 5.0 percent. At Day 180, a single dose of PCSK9si was associated
with an up to 53 percent reduction in LDL-C, with a least squares
mean percent lowering of 47.0 percent in the 300 mg dose
cohort.
In a previous multiple ascending dose study, PCSK9si was
associated with maximal PCSK9 knockdown of 94.4 percent with mean
maximum knockdown of up to 88.5 ± 1.6 percent and maximal LDL-C
reduction of 83.0 percent with mean maximum lowering of up to 64.4
± 5.4 percent.
PCSK9si was generally well tolerated following single and
multiple subcutaneous dose administration, with no serious adverse
events or discontinuations due to adverse events.
The Medicines Company and Alnylam
Pharmaceuticals are collaborating in the advancement of
PCSK9si per their agreement formed in early 2013. Under the terms
of the agreement, Alnylam completed certain pre-clinical studies
and the Phase 1 clinical study, with The Medicines
Company leading and funding the development of PCSK9si from
Phase 2 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 mission is
to create transformational solutions to address the most pressing
healthcare needs facing patients, physicians and providers in three
critical therapeutic areas: serious infectious disease care,
cardiovascular care and surgery and perioperative care. The Company
is headquartered in Parsippany, New Jersey, with global innovation
centers in California and Switzerland.
Forward Looking Statements
Statements contained in this press release 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," “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
our product candidates, including the ORION-1 study of PCSK9si,
will advance in the clinical process on a timely basis, or at all,
or succeed in achieving their specified endpoints; whether
physicians, patients and other key decision makers will accept
clinical trial results; whether the Company will make regulatory
submissions for its product candidates on a timely basis, or at
all; whether its 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 from time to
time in the Company's periodic reports and registration statements
filed with the Securities and Exchange Commission including,
without limitation, the risk factors detailed in the Company's
quarterly report on Form 10-Q filed with the Securities and
Exchange Commission on August 5, 2016, which are incorporated
herein by reference. The Company specifically disclaims any
obligation to update these forward-looking statements.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161018005864/en/
The Medicines CompanyMediaMeg Langan, 973-290-6319Vice
Presidentmargaret.langan@themedco.comorInvestor RelationsKrishna Gorti, MD,
973-290-6122Vice President, Investor
RelationsKrishna.Gorti@themedco.com
Medicines (NASDAQ:MDCO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Medicines (NASDAQ:MDCO)
Historical Stock Chart
From Apr 2023 to Apr 2024