MicuRx Pharmaceuticals Files Investigational New Drug Application for MRX-I
HAYWARD, Calif. and SHANGHAI, March 15 /PRNewswire/ — MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced that it has filed an Investigational New Drug (IND) application with the State Food and Drug Administration (SFDA) in China for MRX-I, its first development-stage antibiotic drug candidate. MRX-I, an orally-administered oxazolidinone, targets multi-drug resistant Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).
“The filing of the first IND just two years since the inception of MicuRx represents a significant accomplishment for our company. This validates our hybrid business model utilizing China’s abundant scientific talent and cost-effective infrastructure coupled with experienced U.S. management guiding discovery and preclinical efforts,” said Zhengyu Yuan, Ph.D., president and chief executive officer of MicuRx Pharmaceuticals, Inc. “This IND application has been accepted by the SFDA with Special Review status, and we expect to initiate a clinical trial in 2010.”
MRX-I: A Safer Oxazolidinone Antibiotic
MRX-I is a next-generation oral oxazolidinone antibiotic for treating methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) infections. Extensive animal studies have demonstrated that MRX-I cures infections due to Gram-positive bacteria including MRSA and VRE effectively. In addition, preclinical toxicology studies have shown that MRX-I is safe, and MicuRx anticipates a superior therapeutic window for this compound.
Multi-Drug Resistance: A Growing Global Public Health Crisis
Modern antibiotics have substantially reduced the threat posed by infectious diseases and contributed to a dramatic drop in mortality rates over the past 40 years. However, pathogenic bacteria resistant to current therapies have evolved over the years and become ubiquitous. The World Health Organization, Centers for Disease Control and the Infectious Disease Society of America have identified multi-drug resistant bacteria as a major public health threat today and into the future. In 2008, more than 65,000 people died of drug-resistant bacteria in the United States. In certain regions, the incidence of drug-resistant MRSA increased almost 70% over the last three years alone. MicuRx’s compounds directly address the escalating problem of multi-drug resistant bacteria, with the potential to be used both in hospital and community-based settings.
About MicuRx Pharmaceuticals, Inc.
MicuRx is discovering and developing novel antibiotics to combat infections due to resistant bacteria. Positioned to capture the benefits of United States research and development expertise together with the high quality, low cost discovery, preclinical and development infrastructure in China, the company has built a pipeline of discovery and development programs for the treatment of Gram-positive bacteria, Gram-negative bacteria and fungal infections. The company has research and development facilities outside San Francisco, CA in the United States and in Shanghai, China.
SOURCE MicuRx Pharmaceuticals, Inc.