Medicines Co. (MDCO) Announces Significant Follow-up Data from ORION-1 Study of PCSK9si in LDL-C Reduction
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The Medicines Company (Nasdaq: MDCO) announced top-line results from the interim analysis with Day 90 follow-up for all 501 patients enrolled in the ongoing ORION-1 study of PCSK9si, its investigational first-in-class PCSK9 synthesis inhibitor. Data from the interim analysis confirm the significant and durable LDL-C reduction demonstrated up to Day 90 in the preceding Phase 1 study. PCSK9si was well tolerated and no material safety issue was observed in the Day 90 interim analysis of unblinded safety data, including no investigational drug-related elevation of liver enzymes, neuropathy or change in renal function. Injection site reactions were infrequent, mild or moderate, and short-lived.
“We are highly encouraged by the strength and consistency of the Day 90 efficacy and safety data from ORION-1, which build significantly on the promise generated by the preceding Phase 1 study of PCSK9si,” said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. “These compelling interim data affirm PCSK9si’s highly-competitive profile and validate PCSK9si’s game-changing potential. We look forward to presenting results from the ORION-1 study, including Day 180 follow-up for up to 200 patients, at the AHA meeting on November 15, 2016.”
David Kallend, MBBS, Vice President and Global Medical Director at The Medicines Company, added, “Based on the results from our ORION-1 Day 90 interim analysis, PCSK9si has again demonstrated robust and durable knockdown of LDL-C, as well as impressive safety and tolerability. These results validate a triannual, and potentially biannual, low volume subcutaneous dose regimen, which we believe represents a compelling, highly-differentiated approach for treating patients with hypercholesterolemia.”
“The thoughtful and robust design of the ORION-1 study has delivered highly impressive interim data,” said John J.P. Kastelein, M.D., Ph.D., Professor of Medicine and Chairman of the Department of Vascular Medicine at the Academic Medical Center of the University of Amsterdam. “The potential for management of hypercholesterolemia with two or three low volume injections per year could open a new, transformative and affordable pathway for patients and physicians in the treatment of atherosclerotic cardiovascular disease.”
The interim analysis of Day 90 follow-up for all 501 patients, as well as top-line data from Day 180 follow-up for up to 200 patients, will be presented in a Late-Breaking Clinical Trials session at the AHA Scientific Sessions 2016 on November 15, 2016 in New Orleans. In order to protect the scientific integrity of the ongoing ORION-1 study, the Company does not expect to provide additional information or make further public statements regarding the results of the study in advance of the ORION-1 presentation at the AHA Scientific Sessions. The Company anticipates that data from Day 180 follow-up in all 501 patients will be completed, analyzed and top-line results disclosed before the end of 2016.
ORION-1 is a placebo-controlled, double-blind, randomized, dose-finding Phase 2 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 dosing no more than two, three or four times per year.
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