Medicines Co. (MDCO) Updtes on ORION-1 Study; Says IDMC Raised No Safety Concerns

October 5, 2016 4:37 PM EDT

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The Medicines Company (Nasdaq: MDCO) provided a progress update on the ongoing ORION-1 study of PCSK9si, its investigational first-in-class PCSK9 synthesis inhibitor.

ORION-1 is a placebo-controlled, double-blind, randomized Phase II trial of single or multiple subcutaneous injections of PCSK9si in patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (e.g., diabetes and familial hypercholesterolemia) and elevated LDL-C despite maximum tolerated doses of LDL-C lowering therapies. The study compares the effect of different doses of PCSK9si and evaluates the potential for a quarterly or bi-annual dosing regimen. The primary endpoint of the study is the percentage change in LDL-C from baseline at Day 180. The study exceeded its enrollment target of 480 patients ahead of schedule, enrolling a total of 501 patients between January 21, 2016 and June 2, 2016.

An interim analysis of Day 90 follow-up for all 501 patients 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. In addition, the Company anticipates that top-line data from Day 180 follow-up for up to 200 patients will be presented at the Late-Breaking Clinical Trial Session and Day 180 follow-up in all 501 patients will be completed, analyzed and top-line results disclosed before the end of 2016.

Safety data from the ORION-1 study is subject to regular, detailed review and assessment by the Independent Data Monitoring Committee (IDMC). The IDMC has raised no safety concerns and made no safety-related study recommendations through its most recent review on August 26, 2016. Moreover, based upon the Company’s review of blinded safety data through September 29, 2016, the most recent date for which safety data has been made available, no material safety issue and, in particular, no drug-related neuropathy, elevation of liver enzymes or changes in renal function, has been observed. At that date, the 501 study patients had treatment exposure of between 4 and 8 months.

“These impressive, emerging safety data support our view that PCSK9si has a highly-competitive profile as compared with anti-PCSK antibodies and we look forward to presenting results from the ORION-1 study at the AHA meeting on November 15, 2016,” said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. “In particular, we believe that PCSK9si has the unique potential to provide new, innovative solutions to patients, payers and providers through a quarterly or, potentially, bi-annual, low-volume subcutaneous dosing regime and by linking the LDL-C monitoring cycle with administration of therapy.”

About ORION-1

ORION-1 is a placebo-controlled, double-blind, randomized Phase II trial of single or multiple subcutaneous injections of PCSK9si in a total of 501 patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (e.g., diabetes and familial hypercholesterolemia) and elevated LDL-C despite maximum tolerated doses of LDL-C lowering therapies. The trial compares the effect of different doses of PCSK9si and evaluates the potential for a quarterly or bi-annual dosing regimen. The primary endpoint of the study is the percentage change in LDL-C from baseline at Day 180.



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