10 May 2018 - - Parsippany, New Jersey-based serious infectious disease care and cardiovascular care specialist The Medicines Company (NASDAQ: MDCO) has presented results of a pre-specified analysis of secondary endpoints from the ORION-1 Phase II study at the 86th European Atherosclerosis Society Congress (EAS 2018) and accepted for publication in Circulation, the journal of the American Heart Association, the company said.
Investigators showed that inclisiran reduces atherogenic lipoproteins in a profound and sustained manner. Atherogenic lipoproteins non-HDL-C, ApoB, VLDL-C and Lp(a) have each been associated with an increased risk of heart attacks and strokes, particularly in high-risk patients.
The selected starting dose for inclisiran in the Phase III trials achieved guideline-recommended goals for ApoB and non-HDL-C for high- and very high-risk patients in 68% to 90% of patients, compared to 25 to 49% of patients given placebo. This effect was highly consistent across patients and stable and sustained for up to 210 days after initial treatment.
ORION-1 was a placebo-controlled, double-blind, randomized Phase II trial of single or multiple subcutaneous injections of inclisiran 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 compared the effect of different doses of inclisiran and evaluated the potential for an infrequent dosing regimen. The primary endpoint of the trial was the percentage change in LDL-C from baseline at Day-180.
Inclisiran is an investigational GalNAc-conjugated RNA interference therapeutic, which inhibits the synthesis of PCSK9 protein in liver cells, thereby reducing liver cell LDL-receptor turnover, and lowering plasma LDL-C.
The Medicines Company and Alnylam Pharmaceuticals, Inc. are collaborating in the advancement of inclisiran. Alnylam has completed certain pre-clinical studies and the Phase I clinical study, with The Medicines Company leading and funding the development of inclisiran from Phase II forward, as well as potential commercialisation.
The Medicines Company's mission is to create transformational solutions to address the most pressing healthcare needs facing patients, physicians, and providers in serious infectious disease care and cardiovascular care. The company is headquartered in Parsippany, New Jersey, with global innovation centers in California and Switzerland.