MicuRx completes MRX-I Phase 1 trial on MRSA and VRE infection

MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced the completion of its Phase 1 clinical trial for MRX-I, its first development-stage antibiotic drug candidate. The agent MRX-I, an oral oxazolidinone antibiotic, targets infections due to multi-drug resistant Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).  

The double-blind, placebo-controlled Phase 1 study explored safety, tolerability and pharmacokinetics of MRX-I, both in a single ascending dosing of up to 1800 mg, and in a 15-day multiple-dose regimens of twice-daily 600 mg and 800 mg. The compound was safe and well-tolerated at all doses tested in 112 healthy male and female volunteers, with no evidence of myelosuppression (evidenced by no platelet reduction). MRX-I was well absorbed, with exposure levels similar to linezolid (Zyvox®). In preclinical testing, MRX-I demonstrated high potency and broad spectrum activity against Gram positive-bacteria including MRSA and VRE infections. MicuRx intends to present full results of the Phase 1 study in the fall of 2012.

"We are extremely pleased with the results of this clinical study, as it shows that MRX-I may represent the next generation of safer oxazolidinone antibiotics, not offered in the field to date," said Zhengyu Yuan, Ph.D., president and chief executive officer of MicuRx Pharmaceuticals, Inc. "Based on the positive results, we expect to initiate Phase 2 clinical trials in both the United States and China, to determine optimal dosing for MRX-I."

SOURCE MicuRx Pharmaceuticals, Inc.