MicuRx Pharmaceuticals (SHA: 688373), a Shanghai-based developer of antibacterial drugs, has announced the successful completion of a Phase I clinical study in China for its new drug candidate MRX-8, which targets gram-negative drug-resistant bacteria.
The randomized, double-blinded, placebo-controlled Phase I study aimed to evaluate the safety, tolerability, and pharmacokinetic characteristics of MRX-8. It included both single and multi-dose escalation phases. The findings indicated that drug exposure to MRX-8 in the human body increased proportionally with the dose. At a projected clinical dose of 2.5mg/kg once daily, MRX-8 is anticipated to yield effective therapeutic results against multidrug-resistant gram-negative bacterial infections. The drug has shown promising safety in the healthy adult Chinese population, with no study withdrawals or terminations due to adverse events and no adverse events reaching CTCAE level 3 or higher.
MRX-8 is an innovative polymyxin antibiotic with a strong potency against gram-negative pathogens, intended to treat infections from multi-drug resistant gram-negative bacteria such as Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Acinetobacter baumannii. The drug has previously completed Phase I clinical trials in the United States in October 2022, demonstrating acceptable safety and pharmacokinetic characteristics at the expected clinical treatment dose in American healthy subjects.- Flcube.com
