PARSIPPANY, N.J.--(BUSINESS WIRE)--The Medicines Company (Nasdaq: MDCO) today announced that full safety and efficacy data from the ORION-1 Phase 2 study of inclisiran, with six- to nine-month follow-up for all patients in the study, will be presented at the American College of Cardiology's 66th Annual Scientific Session (ACC.17), to be held March 17-19, 2017, in Washington D.C. The ORION-1 study will be presented in the “Late-Breaking Clinical Trials - Featured Clinical Research 1” session at 1:30 p.m., Eastern time, on Friday, March 17, 2017, by the ORION-1 principal investigator, Kausik K. Ray, M.D., MPhil (Cantab), FRCP, Professor of Public Health, Imperial College London.
“We are honored to be included in ACC.17 and excited that important additional data from the ORION-1 study of inclisiran will be presented in a Late-Breaking Clinical Trials session,” said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. “We continue to be highly-encouraged by the strength and consistency of the ORION-1 data, and believe that inclisiran has the potential to provide a highly-differentiated treatment for atherosclerotic cardiovascular disease.”
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.
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.
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.