Compelling safety and efficacy data from Day
180 interim analysis
Inclisiran continued to demonstrate significant
and durable LDL-C reduction, reaffirming the potential for a
highly-differentiated dosing regimen of two or three injections per
year
Inclisiran continued to demonstrate high
standards of safety and tolerability
The Medicines Company reinforces its commitment
to advancing the development of inclisiran with initiation of
ORION-2 study (homozygous familial hypercholesterolemia) and
ORION-3 study (open-label, active comparator extension study for
patients completing ORION-1)
The Medicines Company (Nasdaq:MDCO) today announced positive
top-line results from the interim analysis with Day 180 follow-up
for all 501 patients enrolled in the ongoing ORION-1 Phase 2 study
of inclisiran, its investigational, first-in-class PCSK9 synthesis
inhibitor. In the interim analysis, inclisiran continued to
demonstrate significant and durable LDL-C reduction, reaffirming
the potential for a highly-differentiated, low-volume dosing
regimen of two or three injections per year. Inclisiran was well
tolerated and no material safety issue, including no
investigational drug-related elevation of liver enzymes, neuropathy
or change in renal function, was observed. Injection site reactions
with inclisiran were infrequent, mild or moderate, and
transient.
"Once again, we are highly encouraged by the strength and
consistency of the safety and efficacy data from ORION-1, which
reaffirm our confidence in the great potential of inclisiran and
reinforce our decision to accelerate the development of this
highly-differentiated and potentially transformational approach to
treating patients with hypercholesterolemia,” said Clive Meanwell,
M.D., Ph.D., Chief Executive Officer of The Medicines Company. “We
continue to focus our resources on thoughtfully and aggressively
advancing inclisiran into Phase 3 development to ensure that this
promising new treatment option is made broadly available to the
millions of at-risk, often non-adherent, patients worldwide who
continue to struggle with high cholesterol using available
therapies. Our initiation of the ORION-2 study and enrollment of
ORION-1 patients into the ORION-3 extension study, both of which we
announced today, demonstrate our strong commitment to these
patients.”
The complete follow-up data for all 501 patients to Day 210
(completion of the ORION-1 study), including Day 180 efficacy data,
has been submitted for presentation at the American College of
Cardiology’s 66th Annual Scientific Session, to be held March 17 –
19, 2017, in Washington, DC. 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 until such time as the data is
presented. The Medicines Company also expects to engage in
discussions with regulatory authorities regarding the Company’s
Phase 3 development plan for inclisiran prior to the initiation of
its pivotal clinical trial, ORION-4.
Initiation of ORION-2 Study
The Medicines Company also announced today that it has initiated
the ORION-2 study of inclisiran in patients with Homozygous
Familial Hypercholesterolemia (HoFH). The study will examine the
efficacy, safety and tolerability of inclisiran in patients with
HoFH.
Initiation of ORION-3 Study
The Medicines Company also announced today that it has initiated
ORION-3, a Phase 2, open-label extension study, with an active
comparator (evolocumab), for patients completing the ongoing
ORION-1 study. The ORION-3 study will evaluate the efficacy, safety
and tolerability of long-term dosing of inclisiran and will also
measure the effects of treatment, including a comparison of the
effects of inclisiran and evolocumab, as well as switching from
evolocumab to inclisiran, on certain clinical and patient-reported
endpoints. Patients completing ORION-1 will receive inclisiran or
evolocumab, based on the treatment received in ORION-1. Those
patients who received inclisiran will receive inclisiran throughout
the ORION-3 study. Those patients who received placebo will receive
evolocumab as comparator for one year, and then switch to
inclisiran for the remainder of the ORION-3 study. The estimated
study period for ORION-3 is four years, or until inclisiran
receives regulatory approval, whichever occurs first. Subject to
discussions with regulatory authorities, the ORION-3 study will be
conducted in parallel with the Phase 3 development program for
inclisiran.
About ORION-1
ORION-1 is a placebo-controlled, double-blind, randomized Phase
2 study of single or multiple subcutaneous injections of inclisiran
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 study compares the
effect of different doses of inclisiran and evaluates the potential
for an infrequent dosing regimen. The primary endpoint of the study
is the percentage change in LDL-C from baseline at Day 180.
About Inclisiran
Inclisiran (formerly known as PCSK9si or 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.
The Medicines Company and Alnylam Pharmaceuticals are
collaborating in the advancement of inclisiran per the companies'
2013 agreement. 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
inclisiran 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.
The Medicines Company 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
inclisiran 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 inclisiran 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 October
27, 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/20170108005037/en/
The Medicines CompanyMediaMeg
Langan, 973-290-6319Vice
Presidentmargaret.langan@themedco.comorInvestorsKrishna Gorti, M.D., 973-290-6122Vice
President, Investor Relationskrishna.gorti@themedco.com
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