Medicines Co., Alnylam Pharma Initiate Phase III Clinical Trial Of Inclisiran

(RTTNews) - The Medicines Co. (MDCO) and Alnylam Pharmaceuticals, Inc. (ALNY) said they have initiated a Phase III clinical program for inclisiran.

The companies will commence patient dosing on November 1, 2017 in the ORION-11 trial, a Phase III study of inclisiran versus placebo in patients with atherosclerotic cardiovascular disease or ASCVD, or ASCVD-risk equivalents such as type 2 diabetes and familial hypercholesterolemia, and elevated LDL-cholesterol or LDL-C despite maximum tolerated doses of LDL-C lowering therapies.

The ORION-11 trial is a double-blind study in which 1,500 eligible patients will be randomized 1:1 to receive either inclisiran or placebo. The primary objective of the study is to evaluate the effect of inclisiran treatment on percent change in LDL-C levels from baseline at Day-510 and time-adjusted percent change in LDL-C levels from baseline between Day-90 and Day-540.

Principal Investigator for ORION-11, Professor Kausik Ray, Professor of Public Health, Imperial College London, UK, and Honorary Consultant Cardiologist, Imperial College NHS Trust, said, "We are very excited to have commenced the inclisiran Phase III clinical program with the ORION-11 trial. The ease of dosing - small volume, subcutaneous injections twice a year, most likely given by healthcare professionals - promises to improve patient adherence to lipid therapy, which has been a significant problem with all other approaches."

The ORION-11 trial is one of four Phase III pivotal trials for inclisiran, which also include the ORION-10 trial in approximately 1,500 ASCVD patients treated in North America.