New Data Presented at the American Diabetes Association 78th Scientific Sessions® Reinforce the Potential of The Medicines C...
June 26 2018 - 7:00AM
Business Wire
The Medicines Company (NASDAQ: MDCO) today announced the
presentation of new data from a pre-specified, sub-group analysis
of dosing, efficacy and safety of inclisiran in patients with
diabetes from the ORION-1 Phase II trial at the American Diabetes
Association (ADA) 78th Scientific
Sessions® in Orlando (ADA 2018).
Professor Lawrence Leiter, Director of the Lipid Clinic,
Associate Director of the Clinical Nutrition and Risk Factor
Modification Centre and an Associate Scientist in the Li Ka Shing
Knowledge Institute of St. Michael’s Hospital in Toronto,
reported the data during an oral presentation at ADA 2018. The data
showed that a subcutaneous injection of 300 mg of inclisiran given
at Day-1 and Day-90 lowered LDL-cholesterol (LDL-C) at Day-180 by
more than 50% in patients with atherosclerotic cardiovascular
disease (ASCVD) and those considered ASCVD-risk equivalents,
regardless of whether those patients had diabetes.
Inclisiran demonstrated a similar adverse event profile in
patients with and without diabetes, including no effects on control
of blood glucose levels over six months.
Commenting on the data, Professor Leiter said, “Individuals with
type 2 diabetes remain at high risk for cardiovascular disease.
These data support the potential of inclisiran as an excellent
option to further lower LDL-C in patients with diabetes, given
inclisiran’s efficacy, much lower injection frequency and clean
safety profile to date.”
Dr. David Kallend, MBBS, Chief Medical Officer of The Medicines
Company, said, “The data presented at ADA 2018 further confirm the
robust and consistent efficacy of inclisiran on atherogenic
lipoproteins across multiple patient populations, irrespective of
their diabetes status. We continue to be encouraged by the emerging
safety information from our ongoing Phase III trials, which are
generating five patient-years of inclisiran safety data each
day.”
About ORION-1
ORION-1 was a placebo-controlled, double-blind, randomized Phase
II trial 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-cholesterol (LDL-C) despite
maximum tolerated doses of LDL-C lowering therapies. The trial
compared the effect of different doses of inclisiran and evaluated
the potential for an infrequent dosing regimen. The primary
endpoint of the trial was the percentage change in LDL-C from
baseline at Day-180.
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 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 in this press release about The Medicines Company
(the Company), the Company’s product candidate, inclisiran, the
timing of clinical trial results, regulatory submissions, product
or indication launches, the Company’s strategy, future financial
results and operations, and future opportunities for the 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," “intends," “estimates," “potential," “outlook,” “may,”
“will,” “would,””could,” and similar expressions are intended to
identify forward-looking statements. There are a number of
important factors that could cause actual results or events to
differ materially from those indicated by such forward looking
statements, including: whether, inclisiran, will advance in the
clinical trials process on a timely basis or at all; whether
clinical trial results will warrant submission of applications for
regulatory approval; whether inclisiran will receive approvals from
regulatory agencies; the extent of the commercial success of
inclisiran, if approved; and such other factors as are set forth in
the risk factors detailed from time to time in the Company’s
periodic reports 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
May 9, 2018, which are incorporated herein by reference. The
Company specifically disclaims any obligation to update these
forward-looking statements whether as a result of new information,
future events or otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180626005490/en/
Investor RelationsThe
Medicines CompanyKrishna Gorti, M.D., (973) 290-6122Vice President,
Investor Relationskrishna.gorti@themedco.com
Medicines (NASDAQ:MDCO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Medicines (NASDAQ:MDCO)
Historical Stock Chart
From Sep 2023 to Sep 2024