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Development of cholesterol efflux promoter discontinued
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The Medicines Company has announced that it will immediately discontinue the clinical development program for MDCO-216, an investigational cholesterol efflux promoter.
Data from the recently completed MILANO-PILOT trial did not demonstrate drug effects on intracoronary atherosclerotic plaque sufficient to warrant further development, according to a company press release.
Data from the trial did, however, show an “excellent” safety profile, according to the release.
MILANO-PILOT was a proof-of-concept, double blind, placebo-controlled, randomized study utilizing IVUS to measure the effect of MDCO-216 on atherosclerotic plaque burden and to evaluate the impact of MDCO-216 on cholesterol efflux. The study involved 120 patients with ACS to assess the safety and efficacy of weekly 20-mg/kg infusions of MDCO-216 for 5 weeks.
MDCO-216 is a complex of dimeric recombinant apolipoprotein A-I Milano and a phospholipid that was under development to improve CV outcomes by reducing plaque burden in patients with atherosclerotic disease. MDCO-216 mimics pre-beta HDL and induces cholesterol efflux, according to the release.
The Medicines Company said in the statement that it is supporting the close out of the MILANO-PILOT trial. Results are scheduled for presentation during a Late-Breaking Clinical Trial session at the American Heart Association Scientific Sessions in New Orleans on Nov. 15.
According to the release, the company will continue development of its PCSK9 synthesis inhibitor, which demonstrated significant and durable LDL reduction in the ORION-1 trial. New data from ORION-1, including 90-day follow-up on 501 patients as well as top-line data from a preliminary analysis of 180-day follow-up on 200 patients, will also be presented during a Late-Breaking Clinical Trial session during the AHA Scientific Sessions.
ORION-1 is a placebo-controlled, double blind, randomized, phase 2 trial of single or multiple subcutaneous injections of the PCSK9 synthesis inhibitor. The trial enrolled 501 patients with atherosclerotic CVD or risk equivalents such as diabetes or familial hypercholesterolemia. The primary endpoint is percent change in LDL from baseline to 180 days, according to the release.