Medicines Co. says data from ORION-1 affirm PCSK9si's highly-competitive profile
The Medicines Company 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. 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,," said Clive Meanwell, M.D., Ph.D., CEO of The Medicines Company. 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."