KOWA TO DISCONTINUE K-877 (PEMAFIBRATE) "PROMINENT" CARDIOVASCULAR OUTCOMES STUDY

RESEARCH TRIANGLE PARK, N.C., April 8, 2022 /PRNewswire/ -- Kowa Research Institute, Inc. announces the decision not to continue the Phase 3 PROMINENT study, taking into consideration the recommendations of the Data Safety Monitoring Board (DSMB). Based on the review of a planned interim analysis, the DSMB concluded that the primary endpoint was unlikely to be met. Notable safety concerns were not raised. Kowa Research Institute, Inc. will continue to pursue the potential of K-877 in new therapeutic areas, including nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), as encouraging data was revealed during the analysis of PROMINENT results.

Full data from the trial will be presented as soon as possible at a future conference.

About K-877 (pemafibrate)

Pemafibrate is a highly potent and selective peroxisome proliferator activator receptor-alpha modulator (SPPARMα). Kowa launched pemafibrate for treatment of hyperlipidemia in Japan under the brand name PARMODIA®.

About the PROMINENT study

The PROMINENT study is an international, multi-center, double-blinded, placebo-controlled, randomized trial which included approximately 850 clinical sites in 24 countries. The trial is registered to ClinicalTrials.gov (NCT03071692). Its primary objective is to investigate whether K-877 reduced the risk of cardiovascular events in high-risk patients with type 2 diabetes, mild-to-moderate hypertriglyceridaemia and low levels of HDL-C treated with statins. The primary endpoint is a composite of nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization and cardiovascular death.

About Kowa Research Institute, Inc.

Kowa Research Institute, Inc. (KRI), headquartered in Research Triangle Park, NC, is a division of Kowa Company, Ltd., a privately held multinational company headquartered in Nagoya, Japan. KRI is responsible for the clinical development of Kowa's new drugs in the United States. For more information about KRI, visit www.kowaus.com.

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SOURCE Kowa Research Institute, Inc.