Interim analysis results from ORION-1, which is evaluating The Medicines Company’s PCSK9si drug, will be presented during a late-breaking trial session at the 2016 American Heart Association scientific sessions (12–16 November, New Orleans, USA). According to a press release, an 90-day analysis of follow-up of all 501 patients enrolled in the study will presented and The Medicines Company anticipates that top-line data from day 180 follow-up for up to 200 patients will also be presented at the session. Furthermore, day 180 follow-up in all 501 patients will be completed, analysed and top-line results disclosed before the end of 2016.
The press release reports that based on review of safety data by the Independent Data Monitoring Committee through August 26, 2016 (unblinded) and the Company through September 29, 2016 (blinded), no material safety issue and, in particular, no drug-related neuropathy, elevation of liver enzymes or changes in renal function, has been observed with the drug.
Clive Meanwell, chief executive officer of The Medicines Company, says: “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. 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.”
ORION-1 is a placebo-controlled, double-blind, randomised Phase II trial of single or multiple subcutaneous injections of PCSK9si in patients with atherosclerotic cardiovascular disease or its risk equivalents (eg., diabetes and familial hypercholesterolaemia) and elevated low density lipoprotein (LDL) cholesterol despite maximum tolerated doses of LDL cholesterol 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 cholesterol from baseline at day 180. The study exceeded its enrolment target of 480 patients ahead of schedule, enrolling a total of 501 patients between 21 January 2016 and 2 June 2016.