After analyzing data from a recent trial, the Medicines Company announced Nov. 7 that it would stop development of MDCO-216, an investigational cholesterol efflux promoter.
The company also said it would increase its investment in PCSK9i, its investigational proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor.
Top-line findings of the MILANO-PILOT study “did not show drug effects on intracoronary atherosclerotic plaque sufficient to warrant further development” in MDCO-216, according to a news release. The full results of the randomized trial will be presented Nov. 15 during a late-breaking clinical trials session at the American Heart Association (AHA) scientific sessions in New Orleans.
Meanwhile, the Medicines Company said that the money saved from stopping the MDCO-216 development program would be reallocated to development of PCSK9i. On Oct. 18, the company announced top-line results of the ORION-1 trial, which showed that patients who received PCSK9i had significant and durable reductions in low-density lipoprotein cholesterol at 90 days.
More results of the ORION-1 study will be presented during the Nov. 15 late-breaking clinical trials session at the AHA scientific sessions, including day 90 follow-up for all 501 patients and top-line data from a preliminary analysis of day 180 follow-up for up to 200 patients.
The FDA approved the first two PCSK9 inhibitors in the summer of 2015: alirocumab (Praluent, Regeneron Pharmaceuticals and Sanofi Aventis) and evolocumab (Repatha, Amgen). Both medications have fallen far short of sales expectations. On Nov. 1, Pfizer announced it was discontinuing development of bococizumab, its investigational PCSK9 inhibitor.
Earlier this year, the Medicines Company sold three FDA-approved cardiovascular medications to Chiesi USA, which agreed to pay $264 million in cash for the rights to sell clevidipine (Cleviprex), cangrelor (Kengreal) and argatroban. The Medicines Company could receive up to $480 million in sales-based milestone payment, as well, but it also assumed up to $50 million in milestone payment obligations.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.