The mortality of chronic heart failure patients remains high. Recombinant human Neuregulin-1 (rhNRG-1, also called Neucardin) is a 61 amino acid peptide that acts directly on damaged heart muscle cells to restore their structure and function. This study will investigate the safety and efficacy of rhNRG-1 to treat stable chronic heart failure.
This randomized, parallel, placebo-controlled, double-blind, multi-center study will assess the safety and efficacy of rhNRG-1 also known as Neucardin as a treatment for stable chronic heart failure.
A total of 120 subjects, who have chronic heart failure with a NYHA classification of II or III, and are on a stable regimen of ACEI/angiotensin receptor blocker (ARB), beta-blocker, and/or diuretic for at least 3 months prior to receiving study medication and anticipated to remain on the stable regimen through the treatment period can enroll as per specific inclusion and exclusion criteria.
Subjects will be hospitalized for 10 days during the treatment period and will be infused subcutaneously with rhNRG-1 or placebo.
AsianScientist (May 27, 2013) – Zensun Sci & Tech, Ltd., a biopharmaceutical company based in Shanghai and San Diego, announced Thursday positive results of four completed Phase II clinical trials for its first-in-class anti-heart failure drug, Neucardin™.
Neucardin™ is a fragment peptide of human Neuregulin 1 that binds to the epidermal growth factor ErbB4 receptor tyrosine kinase (RTK) on cardiac myocytes. Neucardin™ targets diseased heart tissue directly via two alternate pathways: one promotes the heart muscle’s structural integrity and the other improves the pumping efficiency of the heart.
The data from the three double-blind, placebo-controlled studies conducted in China and Australia and interim results from the United States Phase II trial demonstrates that Neucardin™ reduced all-cause mortality, improved heart function, reduced heart volumes, improved exercise capacity and quality of life on top of current standard of care in patients with chronic heart failure (CHF).
“Current treatments for chronic heart failure have improved mortality; however, they have reached their potential and novel therapeutic approaches are required if outcomes in these patients are to improve,” said Dr. Inder Anand, a Steering Committee Member for the United States clinical trial, Professor of Medicine at the University of Minnesota and Director of the Heart Failure Program at the Minneapolis VA Medical Center.
A total of 678 people with CHF have participated in the Neucardin™ clinical studies. Overall, the Phase II clinical studies demonstrated a 3 to 5 percent placebo corrected improvement in left ventricular ejection fraction (LVEF).
Based on these clinical trial data, Zensun has filed a New Drug Application (NDA) in China to obtain accelerated market approval, and is planning a Phase III clinical program in the United States.
Source: Zensun Pharma.
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