Shanghai-based antibacterial drug developer MicuRx Pharmaceuticals (SHA: 688373) has announced the conclusion of Phase I of its first-in-human study for MRX-8, a new drug targeting gram-negative drug-resistant bacteria, in the United States. The results demonstrated that at the expected clinical dose, MRX-8 exhibited an acceptable safety and pharmacokinetic profile in healthy American subjects.
Pharmacokinetic/Pharmacodynamic Studies
The in vivo and in vitro pharmacokinetic/pharmacodynamic (PK/PD) studies for MRX-8, conducted in collaboration with David R. Andes from the University of Wisconsin and published in Antimicrobial Agents and Chemotherapy, showed that the area under the curve (AUC) of MRX-8 correlates with its antibacterial efficacy. In the Phase I study in the US, after the estimated clinical treatment dose of 1 mg/kg administered twice a day, MRX-8 produced AUC data in the human body. This indicates that the drug can achieve ideal efficacy for infections caused by Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumannii. Additionally, data on the occurrence of kidney damage under high-dose administration were accumulated.
Clinical Trials in China
MRX-8 is also undergoing Phase I clinical trials in China. MicuRx’s Category 1 innovative antibiotic contezolid (MRX-I) entered the National Reimbursement Drug List (NRDL) in 2021 and received marketing approval in June of the same year. This progress highlights MicuRx’s commitment to advancing its pipeline of antibacterial drugs in both domestic and international markets.
Future Outlook
The positive results from the Phase I study of MRX-8 in the US underscore its potential as a novel treatment option for drug-resistant bacterial infections. MicuRx Pharmaceuticals continues to focus on developing innovative antibiotics to address the growing challenge of antimicrobial resistance.-Fineline Info & Tech
