PARSIPPANY, N.J.--(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.”
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.
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.
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.