The Medicines Co. Posts Positive Phase 1 Data For CAD Drug

The Medicines Company presented positive data from a new Phase 1 study investigating its lipid-modifying agent MDCO-216 as treatment for reducing atherosclerotic disease.

MDCO-216 is a complex of recombinant ApoA-I Milano and phospholipid (POPC) resembling a pre-beta-like high-density lipoprotein (HDL) particle. Previous clinical findings show that human carriers of the ApoA-1 Milano variant exhibit a decreased incidence of cardiovascular disease. The investigational drug has the potential to modify atherosclerotic disease by helping reverse cholesterol transport.

In the randomized, placebo-controlled, single ascending dose Phase 1 study, 24 healthy participants and 24 patients with coronary artery disease (CAD) received a 2-hour infusion of MDCO-216. Results show that MDCO-216 modified key lipid parameters. Dose-dependent increases were observed in ApoA-1, phospholipids, and pre-beta 1 HDL. Decrease in Apo E and HDL-C was noted while prominent and sustained increases in triglyceride was observed. The drug has no significant effect on other lipid and lipoprotein parameters but the results registered increases in HDL particle size and a shift to bigger HDL particles. The drug also markedly increased ABCA1-mediated efflux, which is being considered as a marker of reverse cholesterol transport. MDCO-216 was reported to be well-tolerated and showed a favorable safety profile in the study.

“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 more importantly, was well-tolerated. 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,” said David Kallend, MBBS (Lon), VP and Global Medical Director for the Lipid Programs at The Medicine Company.

The company presented the trial results, which it announced a few days before, at The American Heart Association’s (AHA) Annual Scientific Sessions held in Chicago. The Medicines Co. said it plans to begin a Phase 2 trial of MDCO-216 in 2015.