MicuRx Expands Global Clinical Trial Program For Oral Antibiotic MRX-I
Tags:
Phase 2
Phase 1
Antibiotic
-- Begins Phase 2 Clinical Study in China, Phase 1 Bridging Study in Australia --
-- Appoints Industry Veteran James Ge to Executive Team --
HAYWARD, Calif. and SHANGHAI, Dec. 19, 2013 /PRNewswire/ -- MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced the initiation of a global clinical development program for its lead compound MRX-I, a novel oxazolidinone antibiotic for treatment of Gram-positive infections including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). In related news, the company announced the appointment of James Ge, M.D., Ph.D., as executive vice president, chief operations and development officer responsible for global development of all MicuRx compounds.
The Phase 2 double-blind, multi-center, active comparator-controlled clinical study will enroll more than 200 patients with complicated skin and skin structure infections in China.
Concurrently, MicuRx is enrolling volunteers in a Phase 1 bridging study in Australia. The Phase 1 study will be performed in healthy subjects to assess the safety and pharmacokinetics of both single and multiple dose regimens of MRX-I in a non-Chinese population. This bridging study is designed to provide essential clinical data to support the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for a Phase 2 study of MRX-I to treat acute bacterial skin and skin structure infections.
"Leveraging the MicuRx US/China hybrid business strategy for discovery and development, we have implemented an aggressive clinical effort to secure global regulatory clearances for our proprietary antibiotics," commented Zhengyu Yuan, Ph.D., president and chief executive officer of MicuRx Pharmaceuticals, Inc. "The newly initiated clinical studies build on the Phase 1 trial in China that demonstrated MRX-I was safe and well tolerated in humans, with no signs of apparent myelosuppression. We believe that MRX-I has potential to be the best-in-class oxazolidinone antibiotic to address the growing global problem of multidrug resistance, and look forward to advancing this compound through development in an expeditious manner."
"The addition of James Ge to our executive management team brings premier industry leadership into our clinical studies and international operations, and we look forward to relying on his insight and direction to ensure accelerated progress of MRX-I clinical studies," continued Dr. Yuan. "We look forward to completing the Chinese Phase 2 and Australian Phase 1 bridging study in 2014, with the US IND filing to follow shortly thereafter."
Dr. Ge brings a broad experience and success in all areas of anti-infective drug development, from discovery through international regulatory approvals. Prior to MicuRx, he served in a variety of executive and escalating management positions at pharmaceutical and biotechnology companies including ALDEA Pharmaceuticals, Kalidex Pharmaceuticals, Calixa Pharmaceuticals (acquired by Cubist Pharmaceuticals), Forest Laboratories, Cerexa Pharmaceuticals (acquired by Forest Laboratories), Peninsula Pharmaceuticals (acquired by JandJ Pharmaceuticals), Genesoft Inc, and Magainin Pharmaceuticals Inc. He has founded or co-founded several biotech franchises, and played a key role in the successful evolution and exit of three antibiotics companies.
About MicuRx Pharmaceuticals, Inc.MicuRx (http://www.micurx.com) 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, cost-efficient discovery, preclinical and development infrastructure in China, the company has built a pipeline of discovery and development programs targeting Gram-positive and Gram-negative pathogens. The company has research and development facilities outside San Francisco, CA in the United States and in Shanghai, China.
SOURCE MicuRx Pharmaceuticals
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