BioCentury
ARTICLE | Clinical News

Medicines Co., Alnylam to begin Phase III program of inclisiran

June 2, 2017 8:32 PM UTC

Next half, The Medicines Co. (NASDAQ:MDCO) and Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) plan to begin placebo-controlled Phase III trials to evaluate 300 mg subcutaneous inclisiran on day 1, 90 and every 6 months thereafter for a total of 4 doses over 18 months in about 3,000 patients with familial hypercholesterolemia and atherosclerotic cardiovascular disease. The primary endpoint will be the change from baseline in LDL-C. The partners plan to submit an NDA to FDA for inclisiran by year end 2019.

The Medicines Co. also plans to begin a cardiovascular outcomes trial (CVOT) in about 14,000 patients with atherosclerotic cardiovascular disease and/or risk equivalents to evaluate LDL-C reduction with inclisiran. The trial’s primary endpoint will be a composite of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI) and fatal and non-fatal ischemic stroke...