The Medicines Company Presents New Phase 1 Data Showing Investigational Agent MDCO-216 Modified Key Lipid Parameters and Was Well-Tolerated in Healthy and Coronary Artery Disease (CAD) Patients
The Medicines Company (NASDAQ:MDCO) today presented findings from a new Phase 1 study showing that a single infusion of MDCO-216, an investigational lipid-modifying agent, in both healthy and CAD patients, modified key lipid parameters including ApoA-1, phospholipids, HDL, pre-beta 1 HDL and Apo E, markedly increased ABCA1 mediated efflux, a potential marker of reverse cholesterol transport and was well tolerated. The study was presented today as part of a poster session at The American Heart Association’s Annual Scientific Sessions in Chicago.
Clinical findings have shown that human carriers of the ApoA-1 Milano variant have a reduced incidence of cardiovascular disease. MDCO-216, currently under development by The Medicines Company, is a complex of recombinant human Apo A1 with phospholipids to emulate an HDL particle. MDCO-216 has the potential to modify atherosclerotic disease by promoting reverse cholesterol transport, and its potential impact on reducing cardiovascular events in acute coronary syndrome (ACS) patients.
“This study provides a signal that MDCO-216 is able to modulate lipid parameters consistent with those humans with the ApoA-1 variant, had an important effect on markers of reverse cholesterol transport such as pre-beta1 HDL and ABCA1 mediated efflux, and importantly was well-tolerated,” commented David Kallend, MBBS (Lon), Vice President and Global Medical Director for the Lipid Programs at The Medicine Company. “These findings support the continued development of MDCO-216 as a potential treatment to help address a currently unmet need in coronary artery disease patients."
In the Phase 1 study, 24 healthy volunteers and 24 patients with documented CAD received a 2-hour infusion of MDCO-216 in a randomized, placebo-controlled, single ascending dose study. Five cohorts of healthy volunteers and four cohorts of CAD patients received doses ranging from 5 - 40 mg/kg. Subjects were followed for 30 days and returned throughout the study for safety assessments. In both healthy volunteers and stable CAD patients, dose dependent increases in ApoA-1, phospholipid and prebeta-1 HDL and decreases in Apo E were observed. Prominent and sustained increases in triglyceride and decreases in HDL-C occurred at doses above 20 mg/kg in both healthy volunteers and patients with CAD. In both subject populations, profound increases in ABCA1 mediated cholesterol efflux were observed. Other lipid and lipoprotein parameters were generally unchanged with increases in HDL particle size and a shift to larger HDL particles. The study also demonstrated that MDCO-216 was well tolerated with no serious adverse events and no other significant adverse safety findings, including laboratory parameters.
About MDCO-216 (ApoA-1 Milano/POPC)
MDCO-216, an investigational product not approved for commercial use in any market, is a complex of recombinant ApoA-I Milano and phospholipid (POPC) manufactured by a new process to resemble a pre-beta-like high-density lipoprotein (HDL) particle. It has the potential to modify atherosclerotic disease by promoting reverse cholesterol transport and may, in the future, be tested in trials to measure reductions in the risk of adverse atherothrombotic events. The Medicines Company expects to initiate a Phase 2 trial of MDCO-216 in 2015.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Statements contained in this press 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" "expects" 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 whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results 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 SEC on November 7, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
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