—Results from ORION-1 interim analysis with
Day 90 follow-up will be presented in Late-Breaking Clinical Trial
Session at American Heart Association (AHA) meeting on November 15,
2016—
—The Company anticipates that top-line data
from Day 180 follow-up for up to 200 patients will also be
presented at the Late-Breaking Clinical Trial Session—
—Based on review of safety data by the
Independent Data Monitoring Committee through August 26, 2016
(unblinded) and the Company through September 29, 2016 (blinded),
no material safety issue and, in particular, no drug-related
neuropathy, elevation of liver enzymes or changes in renal
function, has been observed—
The Medicines Company (NASDAQ:MDCO) today provided a progress
update on the ongoing ORION-1 study of PCSK9si, its investigational
first-in-class PCSK9 synthesis inhibitor.
ORION-1 is a placebo-controlled, double-blind, randomized Phase
II trial of single or multiple subcutaneous injections of PCSK9si
in 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 study
compares the effect of different doses of PCSK9si and evaluates the
potential for a quarterly or bi-annual dosing regimen. The primary
endpoint of the study is the percentage change in LDL-C from
baseline at Day 180. The study exceeded its enrollment target of
480 patients ahead of schedule, enrolling a total of 501 patients
between January 21, 2016 and June 2, 2016.
An interim analysis of Day 90 follow-up for all 501 patients
will be conducted and presented in the Late-Breaking Clinical Trial
Session at the AHA Scientific Sessions 2016 on November 15,
2016 in New Orleans. In addition, the Company anticipates
that top-line data from Day 180 follow-up for up to 200 patients
will be presented at the Late-Breaking Clinical Trial Session and
Day 180 follow-up in all 501 patients will be completed, analyzed
and top-line results disclosed before the end of 2016.
Safety data from the ORION-1 study is subject to regular,
detailed review and assessment by the Independent Data Monitoring
Committee (IDMC). The IDMC has raised no safety concerns and made
no safety-related study recommendations through its most recent
review on August 26, 2016. Moreover, based upon the Company’s
review of blinded safety data through September 29, 2016, the most
recent date for which safety data has been made available, no
material safety issue and, in particular, no drug-related
neuropathy, elevation of liver enzymes or changes in renal
function, has been observed. At that date, the 501 study patients
had treatment exposure of between 4 and 8 months.
“These impressive, emerging safety data support our view that
PCSK9si has a highly-competitive profile as compared with anti-PCSK
antibodies and we look forward to presenting results from the
ORION-1 study at the AHA meeting on November 15, 2016,” said Clive
Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines
Company. “In particular, we believe that PCSK9si has the unique
potential to provide new, innovative solutions to patients, payers
and providers through a quarterly or, potentially, bi-annual,
low-volume subcutaneous dosing regime and by linking the LDL-C
monitoring cycle with administration of therapy.”
About ORION-1
ORION-1 is a placebo-controlled, double-blind, randomized Phase
II 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 a quarterly or
bi-annual dosing regimen. The primary endpoint of the study is the
percentage change in LDL-C from baseline at Day 180.
About PCSK9si
PCSK9si (also known as ALN-PCSsc) is an investigational
GalNAc-conjugated RNAi therapeutic targeting PCSK9 – a genetically
validated protein regulator of LDL receptor metabolism – being
developed for the treatment of hypercholesterolemia. 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 turning off 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 I clinical study, with The Medicines
Company leading and funding the development of PCSK9si 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
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," “views” 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 the clinical trials for our product
candidates, including the ORION-1 trial of PCSK9si, will advance in
the clinical process on a timely basis or at all or succeed in
achieving their specified endpoints; whether the Company is able to
disclose clinical trial results on a timely basis; 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 SEC on August 5, 2016 , 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/20161005006433/en/
MediaRusso PartnersMatt
Middleman,
M.D.212-845-4272matt.middleman@russopartnersllc.comorInvestorsKrishna Gorti, M.D.Vice President,
Investor Relations973-290-6122Krishna.Gorti@themedco.com
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