Cholesterol new drugs achieve clinically excellent results, significantly lowering LDL-C
October 20, 2016 Source: WuXi PharmaTech
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Today, The Medicines Company Biopharmaceuticals announced that its ongoing ORION-1 clinical trial has achieved medium-term results. In this study, 501 patients received the first-in-class PCSK9 synthesis inhibitor, a new hypercholesterolemia drug, PCSK9si, and interim data analysis confirmed that patients showed significant after 90 days of follow-up. Long-lasting LDL-C levels are reduced. Moreover, PCSK9si is well tolerated with no serious adverse reactions.
PCSK9si is a synthetic inhibitor of the pre-study protein converting enzyme subtilisin kexin type 9 (PCSK9) and is being developed for the treatment of hypercholesterolemia. PCSK9 is a genetically validated protein regulator for LDL receptor metabolism. PCSK9si inhibits PCSK9 synthesis in the liver through the mechanism of RNA interference (Enhanced Stabilization Chemistry (ESC)-GalNAc-siRNA technology from the partner company Alnylam Pharmaceuticals) In order to effectively regulate high cholesterol.
The above clinical trial ORION-1 is a placebo-controlled, double-blind, randomized phase 2 study in a total of 501 patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk (eg diabetes and familial hypercholesterolemia) Single or multiple subcutaneous injections of PCSK9si in patients). The trial compared the effects of different doses of PCSK9si and assessed the likelihood of not being administered more than twice, three times or four times per year. Detailed data will be published at the American Heart Association meeting on November 15, 2016, and will include a 90-day follow-up of all 501 patients and a preliminary analysis of 180 days of follow-up of up to 200 patients.
Dr. Clive Meanwell, CEO of The Medicines Company, said: "The validity and safety data for the 90-day follow-up of the ORION-1 trial are very encouraging. The strength and consistency of these results is based on the previous Phase 1 clinical study of PCSK9si. Based on these compelling interim data, the PCSK9si is highly effective and has great potential."
David Kallend, vice president and global medical director of The Medicines Company, added: "The interim analysis of the 90-day follow-up of ORION-1 once again demonstrates that PCSK9si can consistently reduce the persistence of LDL-C and its impressive safety. And tolerability. These results validate three times a year, and potentially two low-dose subcutaneous dosing regimens per year, which we consider to be a powerful and effective method for treating patients with hypercholesterolemia."
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