- Interim results from ongoing ORION-3
study demonstrated sustained lowering of LDL-C by more than 50
percent, with time-averaged absolute reductions of 59.4 mg/dL
- No material safety issues observed in
the study
- Pivotal Phase 3 readouts for inclisiran
expected in 3Q-2019 followed by regulatory filings expected in the
U.S. in 4Q-2019 and Europe in 1Q-2020
The Medicines Company (NASDAQ: MDCO) today announced interim
results from the ongoing ORION-3 open-label extension study (Group
1, n=290) which showed that twice-a-year dosing with inclisiran
sodium 300 mg resulted in consistent lowering of low density
lipoprotein cholesterol (LDL-C) by more than 50 percent with
overall follow-up of up to three years. Inclisiran was well
tolerated, and no material safety issues were observed in the
study. These results were presented today during a late-breaking
clinical trial session at the National Lipid Association (NLA)
Scientific Sessions in Miami.
Inclisiran, the first cholesterol-lowering therapy in the siRNA
class, is in Phase 3 clinical development to evaluate its ability
to lower LDL-C through twice-a-year dosing. Pivotal Phase 3
readouts for inclisiran are expected in the third quarter. ORION-3
(n=382) is an open-label extension study of the Phase 2 ORION-1
trial to assess the efficacy, safety and tolerability of long-term
dosing of inclisiran.
“The cumulative effects of elevated LDL-C over time continue to
place millions of people with atherosclerosis at increased
cardiovascular risk, despite the widespread use of LDL
cholesterol-lowering treatments,” said John J.P. Kastelein, M.D.,
Ph.D., ORION-3 study chair and Professor of Medicine at the
Department of Vascular Medicine at the Academic Medical Center of
the University of Amsterdam, The Netherlands. “These new data from
ORION-3 provide further evidence of inclisiran’s unprecedented
ability to deliver persistent LDL-C reductions over a prolonged
period, which can help more patients reliably achieve LDL-C goals.
Inclisiran also demonstrated a favorable safety profile, an
important consideration given the long duration of LDL-C
treatment.”
In this interim analysis of ORION-3, inclisiran demonstrated a
51 percent (64.0 mg/dL, p<0.001) reduction in LDL-C levels
through day 210, which was the study’s primary endpoint. The
time-averaged absolute LDL-C reduction with inclisiran was 59.4
mg/dL (p<0.001). These effects were independent of dose level
and number of doses of inclisiran previously given in the ORION-1
study.
With overall follow-up of approximately three years from the
first dose in ORION-1, no change in the overall safety profile was
observed in this interim analysis of ORION-3 compared to the
one-year follow-up in ORION-1. Inclisiran was well tolerated and no
material safety issues were observed, including no elevations of
liver enzymes or changes in renal function considered related to
study medication. Clinically relevant injection site reactions were
infrequent, mild or moderate, and transient, in line with
observations in ORION-1.
“The strong data from ORION-3 bolster our confidence in
inclisiran’s robust therapeutic profile which offers a vastly
different value proposition compared to any other LDL-C lowering
option,” said Mark Timney, Chief Executive Officer of The Medicines
Company. “We truly believe that inclisiran could be a game-changer
in cardiovascular care, providing simplicity and confidence to the
treating physician and the treated patient that LDL cholesterol is
lowered.”
“These new results reinforce that the potent, durable and
consistent LDL-lowering effects of inclisiran continue over the
long term with twice-a-year dosing that we believe can address the
challenges of treatment adherence through improved therapeutic
coverage and persistence,” said Peter Wijngaard, Ph.D., Chief
Development Officer of The Medicines Company. “We also remain
encouraged by inclisiran’s safety profile.”
More than 3,000 patient-years of inclisiran safety data have
been accumulated to date in the ORION program. The data from
ORION-3, as well as ongoing review of blinded data to date from the
Phase 3 trials, show no material safety issues; data are at least
as favorable as those generated and published from the ORION-1
Phase 2 trial.
Background on ORION-1 and ORION-3
ORION-1 is a Phase 2, placebo-controlled, double-blind,
randomized trial to evaluate the efficacy, safety, and tolerability
of inclisiran in participants with atherosclerotic cardiovascular
disease (ASCVD) or ASCVD-risk equivalents and elevated LDL-C
despite maximum tolerated dose of LDL-C lowering therapies.
Subjects who completed ORION-1 and met all inclusion and
exclusion criteria enrolled into ORION-3 in two groups. In Group 1,
subjects (n=290) previously treated with any inclisiran dose in
ORION-1 received twice-a-year injections of inclisiran sodium 300
mg. The ORION-3 primary endpoint was mean percent change in LDL-C
from the ORION-1 baseline value, measured at day 210 in Group 1.
The interim analysis of ORION-3 presented on May 18, 2019, reported
safety and efficacy of inclisiran for Group 1 only (NLA Scientific
Sessions, “Long-term twice-a-year dosing of inclisiran, a novel
siRNA therapy, results in persistent LDL-C lowering in Phase II
extension study (ORION-3),” speaker: John J. P. Kastelein, M.D.,
Ph.D.).
In Group 2, subjects (n=92) previously treated with placebo in
ORION-1 received one year of treatment with evolocumab (140 mg
injections every two weeks) followed by three years of treatment
with inclisiran sodium 300 mg given on day 360 and 450 and every
six months thereafter. For Group 2, safety and efficacy of
switching from evolocumab to inclisiran will be assessed in an
exploratory manner. Follow up for Group 2 is ongoing, and
completion is projected to occur in 2022 followed by anticipated
presentation of data in a scientific forum.
Investor Conference Call and Webcast Information
The Company will host a conference call and webcast today at
5:30 p.m., U.S. Eastern Standard Time. During the call, the
Company’s management and clinical trial investigators will discuss
interim results from the ongoing ORION-3 study. The dial-in
information to access the call is as follows immediately below. A
live audio webcast of the conference call may be accessed in the
“Investors & Media” section of The Medicines Company
website.
U.S./Canada: (877) 407-0312International:
(201) 389-0899Conference ID: 13690839
A taped replay of the conference call will be available for
approximately one week. The replay may be accessed as follows
immediately below. An archived webcast will be available after the
call concludes.
U.S./Canada: (877) 660-6853International:
(201) 612-7415Conference ID: 13690839
About Inclisiran
Inclisiran, the first cholesterol-lowering therapy in the siRNA
class, is The Medicines Company’s investigational therapy in Phase
3 clinical development to evaluate its ability to lower low-density
lipoprotein cholesterol (also known as LDL-C or bad cholesterol)
through twice-a-year dosing. As a siRNA, inclisiran directly
targets messenger RNA and harnesses one of the body’s powerful
natural mechanisms, RNA interference, to prevent production of the
PCSK9 protein at its source in the liver and facilitate removal of
LDL-C from the bloodstream. In Phase 2 studies, inclisiran provided
clinically significant LDL-C reductions greater than 50 percent in
addition to the effects of statins and/or ezetimibe, and LDL-C
reductions were sustained throughout the six-month dosing interval.
Inclisiran is not yet approved for use by the FDA or any other
regulatory authority. The Medicines Company obtained global rights
to develop, manufacture and commercialize inclisiran under a
license and collaboration agreement with Alnylam
Pharmaceuticals.
Commercial Opportunity
In the U.S. alone, approximately 15.1 million people are
currently treated with lipid-lowering therapies to manage
cardiovascular risk, but only one out of five (or 2.4
million) is successfully reaching LDL-C targets with
current therapies. This implies a population of at least 12.7
million Americans who could potentially benefit from the
investigational candidate inclisiran, the first
cholesterol-lowering siRNA with the potential to deliver potent,
durable and consistent lowering of LDL-C levels via twice-a-year
dosing.
About The Medicines Company
The Medicines Company is a biopharmaceutical company with a
singular, relentless focus on addressing the greatest global
healthcare challenge and burden today – cardiovascular disease. Our
purpose is to halt the deadly progression of atherosclerosis and
the cardiovascular risk created by high levels of LDL-C, or bad
cholesterol. The Company is headquartered in Parsippany, New
Jersey. For more information, please visit
www.themedicinescompany.com and follow us on Twitter @MDCONews and
LinkedIn.
Forward-Looking Statements
Statements contained in this news 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,” “plans,”
“expects,” “should,” 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 the ability of the Company to effectively
develop inclisiran; whether inclisiran will advance in the clinical
trials process on a timely basis or at all, or succeed in achieving
its specified endpoints; whether the Company will make regulatory
submissions for inclisiran on a timely basis; whether its
regulatory submissions will receive approvals from regulatory
agencies on a timely basis or at all; the extent of the commercial
success of inclisiran, if approved; the strength, durability and
life of the Company’s patent protection for inclisiran and whether
the Company will be successful in extending exclusivity; 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 (SEC),
including, without limitation, the risk factors detailed in the
Company's Quarterly Report on Form 10-Q filed with the SEC on April
26, 2019, 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: https://www.businesswire.com/news/home/20190518005027/en/
Investor RelationsKrishna Gorti, M.D.Vice President,
Investor Relations973 290 6122krishna.gorti@themedco.com
Media InquiriesMichael BlashVice President,
Communications973 290 6100michael.blash@themedco.com
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