Zensun Announces the Investigation of Neucardin for Chronic Heart Failure Receives Fast Track Designation From the US FDA

SAN DIEGO, August 28, 2019 (Newswire.com) - ​​​​​​​Zensun USA, Inc., a wholly-owned subsidiary of Zensun Sci & Tech Co. Ltd., Shanghai, announced that the investigation of NEUCARDIN^®, its Recombinant human neuregulin-1 fragment, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of Chronic Heart Failure (CHF). NEUCARDIN^®, the lead drug candidate from the company’s cardiac therapy program, was also recently granted “priority review” for its conditional approval application in China by the National Medical Products Administration (NMPA) (formerly the CFDA).

Under the U.S. FDA Modernization Act of 1997, the Fast Track process was designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. A potential drug that receives Fast Track designation is eligible for Accelerated Approval, which provides for a potential approval by the FDA on the basis of a demonstrated effect on a surrogate endpoint deemed reasonably likely to predict clinical benefit, and Rolling Review, which facilitates the submission of individual sections of a New Drug Application (NDA) as they are completed for review by the FDA. Moreover, Fast Track designation for a potential drug may allow more frequent meetings between the sponsor and FDA to discuss the proposed development plan and ensure collection of appropriate data needed to support approval, as well as possibly more frequent written correspondence from FDA about such matters as the suitability of designs for proposed clinical trials. Many drugs that are eligible for Fast Track designation are also considered appropriate to receive Priority Review, an additional designation that may reduce the time required for FDA review.

"We are extremely pleased that the U.S. FDA has granted Fast Track designation to NEUCARDIN® for the possible treatment of chronic heart failure, recognizing that our first-in-class biologic drug candidate may address significant unmet medical needs in patients diagnosed with mild- to moderate-heart failure. The Fast Track designation may improve both the speed and quality of our development program for NEUCARDIN® as it facilitates our interactions with the U.S. FDA towards further evaluating the safety and efficacy of NEUCARDIN® in patients facing worsening heart failure."

Mingdong Zhou, PhD, Chief Executive Officer

“We are extremely pleased that the U.S. FDA has granted Fast Track designation to NEUCARDIN^® for the possible treatment of chronic heart failure, recognizing that our first-in-class biologic drug candidate may address significant unmet medical needs in patients diagnosed with mild- to moderate-heart failure,” said Mingdong Zhou, Ph.D., Chief Executive Officer of Zensun Sci & Tech Co. Ltd. “The Fast Track designation may improve both the speed and quality of our development program for NEUCARDIN^® as it facilitates our interactions with the U.S. FDA towards further evaluating the safety and efficacy of NEUCARDIN^® in patients facing worsening heart failure.”

Background on Chronic Heart Failure and NEUCARDIN^®

Heart failure is a highly prevalent disease that afflicts roughly 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. Heart failure is a disease of aging populations, and besides the U.S., areas including Europe and Asia are in crisis mode as the population is aging and the prevalence of heart failure is growing rapidly. Moreover, due to the shrinking number of drugs being developed for heart failure by sponsors, novel therapeutics in this disease area are dwindling and in dire need.

NEUCARDIN^® is a recombinant human neuregulin-1 (rhNRG-1) fragment peptide of the neuregulin-1 beta 2 alpha isoform (rhNRG-1β2α), which is being developed as a parenteral (intravenous [IV] or subcutaneous [SC]) agent for the treatment of chronic heart failure (HF) with reduced ejection fraction (HFrEF). Recombinant hNRG-1β2α has been shown in animal models to activate the ErbB2/ErbB4 receptor tyrosine kinases expressed in cardiac myocytes to modulate gene and protein expression, promote sarcomere structural re-organization, increase cardiac contractility/relaxation and promote reverse ventricular remodeling in animal models of HF. To date, there are no approved chronic HF therapies that work directly through ErbB2/ErbB4 receptor tyrosine kinases in cardiac myocytes; therefore, NEUCARDIN^® is a new molecular entity and novel “first-in-class” agent to treat a serious condition with unmet medical needs.

Zensun has met with the U.S. Food and Drug Administration’s Division of Cardiovascular and Renal Products during the U.S. End-of-Phase-2 meeting to discuss its progress in the development of NEUCARDIN^® as a potential treatment for patients with CHF (HFrEF) and the company’s plans for its further development. In addition to a previous Phase-2 multicenter randomized placebo-controlled clinical trial in the U.S., Zensun Sci & 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.

About Zensun Sci & Tech. Co. Ltd.

Zensun is a clinical-stage biopharmaceutical company with sites in China (Shanghai) and the USA (San Diego, CA) and focused on the discovery and development of novel therapeutics that modulate diseased organ function for the potential treatment of serious diseases and medical conditions. Zensun’s lead drug candidate, NEUCARDIN^®, is a potential “First-in-Class” drug with mechanism of regulation of cardiac myosin light chain kinase (cMLCK) activity, as a prospective treatment for diseases and conditions associated with aging, cardiac function, or ischemia.

Additional information about Zensun can be obtained at www.zensunus.com (English) or www.zensun.com (Chinese).

This press release contains statements that reflect the company’s current beliefs and expectations about the future as of the respective dates indicated herein. The forward-looking statements herein are based on the company’s beliefs and expectations about the future and a number of assumptions about the company’s operations and the markets for the company’s products. The forward-looking statements are subject to a number of known and unknown factors, including factors beyond the company’s control, and are subject to significant risks and uncertainties which may cause the company’s actual results or performance to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are not a guarantee of future performance. Accordingly, you should not place undue reliance on such forward-looking statements or any forward-looking information. As noted above, the company and its directors, officers, employees, affiliates, advisers and representatives have no obligation and do not undertake to update or otherwise revise such opinions or forward-looking statements to reflect new information, events or circumstances that occur after the date of the document.

NEUCARDIN is a trademark of Zensun Sci. & Tech. Co. Ltd.

Media Contact:

Daniel Rines, Ph.D.
VP of Business Development
[email protected]

Source: Zensun USA, Inc.