PARSIPPANY, N.J.--(BUSINESS WIRE)--The Medicines Company (NASDAQ: MDCO) today announced that randomization of more than 1,500 patients in the ORION-10 trial in the United States has been completed in only 12 weeks – considerably beating its goal of 22 weeks. ORION-10 is a double-blind, randomized Phase III trial designed to confirm the efficacy and safety of inclisiran, an investigational agent which is potentially a first-in-class lipid-lowering drug to reduce LDL-cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD). In the trial, patients are randomized to inclisiran sodium 300 mg or placebo given subcutaneously on days 1, 90, 270 and 450 – then followed to the end of the study at day 540 (18 months). ORION-10 is one of three similar trials designed to confirm inclisiran safety and efficacy and will provide key data required for NDA and MAA submission in the United States and Europe. Two other trials (ORION-9 in heterozygous familial hypercholesterolemia (HeFH) performed in North America, Europe and South Africa, and ORION-11 in ASCVD performed in Europe) completed enrollment earlier this year – also ahead of schedule.
“A total of 3,660 subjects have been randomized in these three large pivotal Phase III LDL-C lowering trials. This means that we are now accruing 10 patient-years of safety data, including five patient-years of safety data with inclisiran, for every day of follow up. These studies will, therefore, rapidly accrue more than 5,500 patient years of safety follow-up for inclisiran, forming the basis of the integrated safety evaluations in the NDA and MAA,” said David Kallend, MB BS, Chief Medical Officer of The Medicines Company.
A fourth pivotal Phase III study in patients with homozygous familial hypercholesterolemia (HoFH), ORION-5, is expected to enroll patients beginning later in 2018 and, following six months of treatment, to provide data for HoFH as part of a comprehensive LDL-C lowering program in a planned NDA and MAA submission near the end of 2019.
“Completion of enrollment in ORION-10 is one of the key milestones in our quest to confirm the promising safety and efficacy data for inclisiran, which were reported during Phase I and Phase II clinical studies,” said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. “We believe that the rapid pace of enrollment in the pivotal trials of the ORION program, as well as the quality of data emerging from this and other trials, reflect the design of the studies, the effective operational support of excellent clinical sites, exceptional work by our team and our partners at PPD, and the apparent ease of use of the protocol and study medication,” continued Dr. Meanwell.
About ORION -10
ORION-10 is a Phase III, placebo-controlled, double-blind, randomized study of ~1,500 patients with ASCVD (coronary heart disease, cerebrovascular disease and peripheral arterial disease), and elevated LDL-C levels above 70 mg/dL – despite maximum tolerated doses of LDL-C lowering therapies, including statins. The primary endpoint of the study is LDL-C reduction from baseline to day 510. The trial also evaluates the safety and tolerability of 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 the terms of 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 presentation about The Medicines Company (the Company), the Company’s products and product candidates, 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,” 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 the Company’s product candidate 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 the Company’s product candidate will receive approvals from regulatory agencies; the extent of the commercial success of the Company’s product candidate, 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 Annual Report on Form 10-K filed with the SEC on March 1, 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.