Kowa Achieves Goal Of Randomizing 10,000 Patients Into Landmark "PROMINENT" Cardiovascular Outcomes Study Of K-877 (Pemafibrate)

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 patients with diabetes who are already taking statins

RESEARCH TRIANGLE PARK, North Carolina, Feb. 19, 2020 /PRNewswire/ -- Kowa Research Institute, Inc., announced the achievement of its goal to randomize 10,000 subjects into its international, multi-center Phase 3 cardiovascular outcomes trial titled "Pemafibrate to Reduce cardiovascular OutcoMes by reducing triglycerides IN patiENts with diabeTes" (PROMINENT). The trial is evaluating triglyceride reduction and increasing functional HDL with K-877 (pemafibrate) in high-risk patients with diabetes with high triglyceride and low HDL-C levels who are already taking statins.

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All PROMINENT participants receive aggressive, standard of care management of cardiovascular risk factors including treatment with high-intensity statins. In addition, patients receive either K-877 or placebo. The trial includes patients with high triglycerides and low HDL with diabetes 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.

Paul Ridker, MD, MPH, FACC, FAHA 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, are co-Principal Investigators of PROMINENT.

"We are pleased to have achieved our goal to randomize 10,000 patients into PROMINENT," said Gary Gordon, MD, President, Kowa Research Institute, Inc. "Cardiovascular disease remains the number one cause of death worldwide. We will maintain focus on ensuring this important study is completed as planned to determine whether K-877 can be a new, valuable tool for physicians managing patients' cardiovascular disease."

About K-877 (pemafibrate) K-877 is a highly potent and selective peroxisome proliferator activator receptor-alpha (PPAR-alpha) modulator (SPPARMalpha), a promising category of metabolic 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- modulator ever developed, and succeeded with K-877, which is at least 1,000 times as potent and selective as other drugs. Kowa has launched pemafibrate for hyperlipidemia in Japan under the brand name PARMODIA®. Kowa's clinical studies have shown K-877 significantly reduces triglycerides, ApoC3, and remnant cholesterol and increases functional HDL and FGF21.

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 [https://c212.net/c/link/?t=0&l=en&o=2723967-1&h=1739151092&u=http%3A%2F%2Fwww.kowaus.com%2F&a=www.kowaus.com].

LIVALO and PARMODIA are registered trademarks of the Kowa group of companies.

Media Contact: Ian Mehr Kowa Research Institute, Inc. 919-433-1600 imehr@kowaus.com [mailto:imehr@kowaus.com]

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Web site: http://www.kowaus.com/

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