The Medicines Company announces positive top-line data for PCSK9 inhibitor
After 90 days, patients who received an investigational proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor known as PCSK9i had significant and durable reductions in low-density lipoprotein (LDL) cholesterol, according to an interim analysis of a phase 1 study.
The Medicines Company, which manufactures PCSK9i, announced the top-line results in an Oct. 18 news release. The full results will be presented in a late-breaking clinical trial session at the American Heart Association (AHA) Scientific Sessions in New Orleans on Nov. 15.
The ongoing ORION-1 study has enrolled 501 patients. The Medicines Company said PCSK9i was well tolerated and that the interim, 90-day analysis showed no safety issues, including no investigational drug-related liver enzymes, neuropathy or change in renal function. The company also said in the release injection site reactions were infrequent, mild or moderate and short-lived.
At the AHA conference, the Medicines Company plans on presenting the full results of the 90-day follow-up in all 501 patients as well as top-line, 180-day results for up to 200 patients. The company expects to release full, 180-day results by the end of the year.
Last summer, the FDA approved the first two PCSK9 inhibitors: alirocumab (Praluent, Regeneron Pharmaceuticals and Sanofi Aventis) and evolocumab (Repatha and Amgen). Sales of the drugs have been sluggish due to their high costs and lack of cardiovascular outcomes data. The companies plan on releasing results from cardiovascular outcomes trials later this year or next year, which could help increase sales.
Other companies are also developing PCSK9 inhibitors. In January, Eli Lilly and Co. announced results of a phase 2 trial that evaluated LY3015014, its PCSK9 inhibitor. Pfizer announced in June that patients who received its PCSK9 inhibitor, bococizumab, in two phase 3 trials had significant reductions in LDL cholesterol after 12 weeks of treatment.
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.