Medicines Co. (MDCO) Says IDM Committee Recommends MILANO-PILOT Study to Continue

August 30, 2016 4:32 PM EDT

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The Medicines Company (Nasdaq: MDCO) provided an update on its clinical dyslipidemia research programs for MDCO-216 (which contains APoA-1 Milano) and PCSK9si (PCSK9 synthesis inhibitor).

MDCO-216. A planned, interim analysis of the first 40 randomized patients completing treatment in the MILANO-PILOT study of MDCO-216 has been reviewed by the Independent Data Monitoring Committee (IDM Committee). Based on the protocol and pre-defined criteria in its Charter, the IDM Committee has reported the 40-patient data to the Company in summary form and recommended that the MILANO-PILOT study continue. The pre-defined, upper statistical boundary for efficacy, which permits early termination of the study by the Company, was not met and, given the limited number of patients included in the first interim analysis, the summary data received by the Company from the IDM Committee are, at this time, inconclusive.

The Company has completed enrollment of the planned 120 patients and expects that results from the MILANO-PILOT study will be presented by its principal investigator, Dr. Steven Nissen of the Cleveland Clinic, in the Late-Breaking Clinical Trial Session at the American Heart Association (AHA) Scientific Sessions 2016 on November 15, 2016 in New Orleans.

PCSK9si. As previously disclosed, the ORION-1 Phase II trial of PCSKsi completed enrollment ahead of schedule. An interim analysis with Day 90 follow-up for all subjects will be conducted and presented in the Late-Breaking Clinical Trial Session at the AHA Scientific Sessions 2016 on November 15, 2016 in New Orleans. The Company expects that Day 180 follow-up in all subjects will be completed, analyzed and presented before the end of 2016.

“We look forward to presenting results from the MILANO-PILOT study and the ORION-1 trial at the American Heart Association meeting in New Orleans on November 15, 2016,” said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. “Atherosclerotic cardiovascular disease (ACD) remains the leading cause of mortality worldwide. Our mission is to improve outcomes in ACD and drive better economics of care for patients, physicians and payers. We had hoped that the 40-patient data from the MILANO-PILOT study would meet the pre-defined efficacy threshold for early termination, but they did not and, so far, the data are inconclusive. The study is continuing and we look forward to receiving full access to the final data.”

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