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MDCO-216, a cholesterol efflux promoter, is discontinued- The Medicines Company

Read time: 1 mins
Last updated: 10th Nov 2016
Published: 10th Nov 2016
Source: Pharmawand

The Medicines Company announced the immediate discontinuation of the clinical development program for MDCO-216, its investigational cholesterol efflux promoter. Data from the recently-completed MILANO-PILOT trial did not show drug effects on intracoronary atherosclerotic plaque sufficient to warrant further development. The safety profile of MDCO-216 was excellent.

Information now available to the Company from the MILANO-PILOT trial of MDCO-216, when evaluated in light of the evolving treatment landscape for atherosclerotic cardiovascular disease, including the emergence of highly-positive data from the ORION-1 trial of the Company�s PSCK9 synthesis inhibitor, drove the Company�s decision to discontinue further investment in the clinical development of MDCO-216. The Company�s decisive move will free up substantial additional capital, which will be reallocated and focused onto the development of its PCSK9 synthesis inhibitor, which demonstrated significant and durable LDL-C reduction in the ORION-1 trial � reaffirming a triannual, and potentially biannual, dosing regimen with high standards of safety and tolerability and a highly-competitive profile. Results from the ORION-1 trial, including Day 90 follow-up for all 501 patients, as well as top-line data from a preliminary analysis of Day 180 follow-up for up to 200 patients, will be presented in the Late-Breaking Clinical Trial Session at the AHA Scientific Sessions 2016, on November 15, 2016, in New Orleans.

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