A phase 3 study evaluating pemafibrate (K-877) to reduce cardiovascular outcomes in high-risk adults with type 2 diabetes has been discontinued.
Pemafibrate is an investigational selective peroxisome proliferator activator receptor-alpha modulator (SPPARMα). The international, multicenter, randomized, double-blind, placebo-controlled PROMINENT study (ClinicalTrials.gov Identifier: NCT03071692) included over 10,000 adults with type 2 diabetes who had mild to moderate hypertriglyceridemia and low levels of HDL-C treated with statins.
Patients were randomly assigned to receive either pemafibrate 0.2mg tablet orally twice daily or placebo. The study aimed to determine whether treatment with pemafibrate could delay the time to first occurrence of any component of the clinical composite endpoint which was nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization and cardiovascular death.
The decision to halt the study was made based on the recommendations of the Data Safety Monitoring Board (DSMB), which concluded that the primary endpoint was unlikely to be met. There were no notable safety concerns raised in the study. Full study data will be presented at a future conference.
The Company intends to continue to pursue pemafibrate in new therapeutic areas, including nonalcholic fatty liver disease and nonalcholic steatohepatitis, based on encouraging data that was shown in the interim analysis of the PROMINENT study.
Kowa to discontinue K-877 (pemafibrate) “PROMINENT” cardiovascular outcomes study. News release. Kowa Research Institute, Inc. April 8, 2022. Accessed April 11, 2022. https://www.prnewswire.com/news-releases/kowa-to-discontinue-k-877-pemafibrate-prominent-cardiovascular-outcomes-study-301520956.html