FB-HRS, LLC Announces US FDA Clearance of IND Application to Initiate Clinical Trial for FBHRS001, a Treatment for Atrial Fibrillation

Philadelphia, PA -- (ReleaseWire) -- 06/22/2020 -- FB-HRS, LLC today announced the US Food and Drug Administration has cleared an Investigational New Drug (IND) application to initiate its Clinical Trial of FBHRS001, a fixed dose combination (FDC) of two drugs, for the treatment of atrial fibrillation. This FDC product is being evaluated for the improved safety and efficacy, in comparison to existing drugs on the market.

Atrial fibrillation is the most common sustained abnormal heart rhythm that affects over 9.3 million people in the United States, over 13 million people in China, and over 30 million people world-wide.

FBHRS001 has been developed through a collaboration between FB-HRS, LLC and Zhendong Pharmaceutical Co., Ltd. to address the efficacy and safety concerns of existing medicines in the atrial fibrillation market today. While most drugs prescribed face challenges with serious adverse effects, such as thyroid dysfunction, liver injury, or sudden cardiac death from induced Torsades de pointes, FBHRS001 has the potential to provide a reduction in adverse effects while being effective in the treatment of atrial fibrillation.

About FB-HRS, LLC
FB-HRS, LLC is a joint venture, co-founded by Frontida BioPharm, Inc. and Heart Rhythm Solutions, Inc., both located in Philadelphia, U.S.A. FB-HRS, LLC focuses on research, development and commercialization of innovative medicines for the treatment of cardiovascular diseases.

About Frontida BioPharm, Inc.
Frontida BioPharm, Inc. is a leading provider of drug delivery technologies, product development and manufacturing services for both small and large pharmaceutical and consumer health companies. Frontida BioPharm is helping our clients and partners reach the market faster, ensuring robust product performance and on-time supply of clinical and commercial products. Our 300,000+ sq.ft manufacturing facilities supply prescription and OTC products, Highly Potent Active Ingredient (HPAI) products, Fixed-dose Combination Products and DEA schedules II – V products. Our three state-of-the-art facilities, two located in Philadelphia, PA and one located in Aurora, IL with 4 commercial packaging lines, equipped with validated product serialization technology, provide packaging services for both commercial products and clinical trial material supplies.

Visit: (https://www.frontidabiopharm.com/)

About Heart Rhythm Solutions, Inc.
Heart Rhythm Solutions is a research based company focusing on preclinical and clinical research for the treatment of cardiac diseases. It has an advanced platform to quickly and effectively screen for drug-related cardiac safety and potential drug targets in the treatment of cardiac arrhythmias.

About Zhendong Pharmaceutical Co., Ltd.
Zhendong Pharmaceutical Co., Ltd. is a leading publicly traded high-tech enterprise integrating research, development, manufacturing of APIs and finished products for both Western medicine and traditional Chinese medicine. Zhendong's products cover broad therapeutic areas, including oncology, cardiovascular, anti-infectious, gastrointestinal, respiratory areas, etc.

Visit: (http://en.zdjt.com/)

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