AsianScientist (Dec. 31, 2013) – MicuRx Pharmaceuticals, Inc. has initiated 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).
The Phase II 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 I bridging study in Australia. The Phase I 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 II 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,” said Zhengyu Yuan, CEO of MicuRx Pharmaceuticals, Inc.
“The newly initiated clinical studies build on the Phase I 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,” he said. “We look forward to completing the Chinese Phase II and Australian Phase I bridging study in 2014, with the US IND filing to follow shortly thereafter.”
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Source: MicuRx Pharmaceuticals, Inc.
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