Trial will evaluate if lowering triglycerides and increasing functional HDL with Kowa's potent selective peroxisome proliferator activator receptor-alpha (PPAR-alpha) modulator, K-877 (pemafibrate) can reduce the elevated risk of cardiovascular disease in high-risk diabetic patients who are already taking statins
RESEARCH TRIANGLE PARK, North Carolina, Jan. 12, 2016 /PRNewswire/ -- Kowa Research Institute, Inc., announced plans to conduct an international, multi-center cardiovascular outcomes trial evaluating triglyceride reduction and increasing functional HDL with K-877 (pemafibrate), in high-risk diabetic patients with high triglyceride and low HDL-C levels who are already taking statins. K-877 is a highly potent and selective peroxisome proliferator activator receptor-alpha (PPAR-alpha) modulator (SPPARMalpha), a promising category of metabolic therapy.
Paul Ridker, MD, director of the Center for Cardiovascular Disease Prevention (CCVDP) at Brigham and Women's Hospital (BWH), a teaching affiliate of Harvard Medical School, and Aruna Pradhan, MD, a cardiologist at BWH, will be co-Principal Investigators of the planned trial.
"This trial is unprecedented," said Gary Gordon, MD, President, Kowa Research Institute, Inc. "Statins are effective in lowering cardiovascular risk among patients with high cholesterol, but residual risk remains, particularly in patients with high triglyceride levels and low HDL-C levels. Kowa will be the first company to run a major, randomized clinical trial investigating whether modulating PPAR-alpha to lower triglycerides and increase functional HDL in diabetic patients can reduce cardiovascular risk when added to statin therapy."
Evidence supports a role for triglyceride-rich lipoproteins and low HDL-C as important contributors to atherosclerosis. Kowa specifically set out to create the most potent and selective PPAR-alpha modulator ever developed, and succeeded with K-877, which is at least 1,000 times as potent and selective as other drugs. Kowa has completed clinical development of K-877 for hyperlipidemia in Japan, and has submitted it to the PMDA for approval as a new drug. Kowa's clinical studies have shown K-877 significantly reduces triglycerides, ApoC3, and remnant cholesterol and increases functional HDL and FGF21.
The Pemafibrate to Reduce cardiovascular OutcoMes by reducing triglycerides IN diabetic patiENTs (PROMINENT) Phase 3 K-877 cardiovascular outcomes trial will recruit an estimated 10,000 high-risk diabetic patients worldwide. All participants will receive aggressive, standard of care management of cardiovascular risk factors including treatment with high-intensity statins. In addition, patients will receive either K-877 or placebo. The trial will include diabetic patients with and without established cardiovascular disease and will test whether K-877 reduces the occurrence of heart attacks, hospitalizations for unstable angina requiring unplanned revascularization, stroke, or death from cardiovascular causes.
"Cardiovascular disease remains the number one cause of death worldwide," said Dr. Gordon. "Reducing residual cardiovascular risk with K-877 would be valuable to physicians managing patients' cardiovascular disease."
About Kowa Company, Ltd. and Kowa Research Institute, Inc.Kowa Company, Ltd. (Kowa) is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various manufacturing and trading activities in the fields of pharmaceuticals, life science, information technology, textiles, machinery and various consumer products. Kowa's pharmaceutical division is focused on research and development for cardiovascular therapeutics (dyslipidemia, type 2 diabetes and atherosclerosis), ophthalmology and anti-inflammatory agents. The company's flagship product, LIVALO® (pitavastatin), is approved in 45 countries around the world.
Kowa Research Institute, Inc., headquartered in Research Triangle Park, NC, is the division of Kowa responsible for the clinical development of Kowa's new drugs in the United States. Kowa Research Institute was established in 1997 in California and began operations at the current location in 2003. For more information about Kowa Research Institute, visit www.kowaus.com [http://www.kowaus.com/].
LIVALO is a registered trademark of the Kowa group of companies.
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