Discontinuation of the MILANO-PILOT trial, in which a cholesterol efflux promoter was being evaluated


News - Nov. 9, 2016

The Medicines Company discontinues the development of MDCO-216, a cholesterol efflux promoter. MDCO-216 is a complex of dimeric recombinant apolipoprotein A-1 Milano and a phospholipid (POPC), and mimics pre-beta HDL. MDCO-216 thereby induces cholesterol efflux, which should have resulted in plaque reduction and improved cardiovascular outcomes. However, according to the press release “the recently completed MILANO-PILOT trial did not show drug effects on intracoronary atherosclerotic plaque sufficient to warrant further development.”

The MILANO-PILOT study was a proof-of-concept, double-blind, placebo-controlled, randomized study in which the impact on cholesterol efflux by MDCO-216 was measured in 120 ACS patients, using intravascular ultrasound (IVUS). Although the efficacy results were disappointing, the drug showed an excellent safety profile of weekly 20 mg/kg MDCO-216 infusions over a 5-week period.

The efficacy results from the MILANO-PILOT trial in combination with the evolving treatment landscape for atherosclerotic cardiovascular disease, including the emergence of highly-positive data from the company’s PCSK9 synthesis inhibitor (ORION-1 trial), drove the company’s decision for discontinuation of MDCO-216. Results from the MILANO-PILOT trial will be presented in the Late-Breaking Clinical Trial Session at American Heart Association (AHA) Scientific Sessions this year in New Orleans. 
Press release The Medicines Company, November 7, 2016

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