Neucardin got Fast Track Designation from US FDA for Chronic Heart Failure

Release Date: 24-Sep-2019

Neucardin is a product of Zensun USA, has received fast track designation from the food and drug administration (FDA) of US. This drug is able to target the heart and hence the designation is given for the use in chronic heart failure. The activity of its recombinant human neuregulin-1 fragment is also got the designation from US FDA.

Heart failure is one of the most prevalent diseases that affect about 26 million people worldwide. Over 1 million new cases of heart failure are diagnosed each year in the U.S. and involve approximately $31 billion dollars spent in the U.S. on heart failure-related care annually. The number of drugs for heart failure is also less and the development in this sector is also restricted.  

Neucardin is a recombinant human neuregulin-1 (rhNRG-1) fragment peptide of the neuregulin-1 beta 2 alpha isoform, which is able to use in heart failure. The route of administration is parenteral route available as intravenous and subcutaneous injection. It is able to improve the ejection of blood from the heart.

The animal model studies show that the recombinant hNRG-1andbeta;2andalpha; has been able to activate the ErbB2/ErbB4 receptor tyrosine kinases expressed in cardiac myocytes to modulate gene and protein expression. This will promote sarcomere structural re-organization and increase cardiac rhythm and promote reverse ventricular remodeling in animal models of heart failure.

Till now, there is no approved chronic heart failure therapy that works directly through ErbB2/ErbB4 receptor tyrosine kinases in cardiac myocytes. Therefore, NEUCARDINandreg; is a prototype drug of new molecular entity that is able to treat a serious condition with unmet medical needs.

After the end of Phase II of clinical trial, Zensun meets the US FDA for discussing the development of Neucardin as a potential drug for the patients with chronic heart failure. The company plans for the further development of Neucardin. Zensun Sci and Tech Co. is conducting an ongoing Phase-3 pivotal trial of Neucardin in China, and preparing for a U.S./multi-national Phase-3 trial. These studies are intended to support potential registration programs with the NMPA and U.S. FDA.