Pharma Focus Asia

MicuRx Completes Phase I Clinical Trial Successfully for Self-Developed MRX-8 Antibacterial Drug in China

Friday, June 07, 2024

Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx," 688373.SH) has successfully completed the Phase I clinical trial for its newly developed injectable polymyxin antibacterial drug, MRX-8, in China. This achievement is a significant step toward confirming MRX-8 as a reliable treatment for infections caused by multidrug-resistant Gram-negative bacteria.

The trial was designed as a randomized, double-blind, placebo-controlled study to evaluate MRX-8’s safety, tolerability, and pharmacokinetic properties in healthy Chinese volunteers. It included phases with single and multiple ascending doses, demonstrating that the drug’s concentration in the body increases in a dose-dependent manner.

Key outcomes include:

  • At a dose of 2.5 mg/kg per day, MRX-8 effectively combats infections caused by multidrug-resistant Gram-negative bacteria.
  • Participants tolerated the drug well, with no severe adverse effects (Grade 3 or higher). Minor adverse events like sensory reduction and a temporary decrease in glomerular filtration rate occurred but resolved without intervention. Two individuals in the multiple dose group experienced mild injection site reactions.

The successful completion of this Phase I trial is a major milestone for MRX-8, reinforcing its potential for further development in treating multidrug-resistant bacterial infections. The results provide strong data support for additional clinical trials and enhance confidence in MRX-8’s future clinical applications.

MicuRx plans to use the data from both U.S. and Chinese trials to guide the next stages of MRX-8’s clinical development. The company is investigating various treatment indications to establish MRX-8 as a valuable option for addressing the challenges posed by multidrug-resistant Gram-negative bacterial infections.

MRX-8 is a novel injectable polymyxin antibiotic developed by MicuRx, designed to treat severe infections caused by multidrug-resistant Gram-negative bacteria. MRX-8 aims to offer improved efficacy while reducing the risk of nephrotoxicity and neurotoxicity through advanced structural modifications.

Earlier trials, including a 2022 Phase I study in the United States, have demonstrated MRX-8’s effectiveness against pathogens such as Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumannii.

Infections caused by multidrug-resistant Gram-negative bacteria present a significant global health challenge, with these pathogens often resistant to multiple antibiotics. Such infections are associated with higher mortality rates compared to infections caused by non-resistant strains. The World Health Organization emphasizes the critical need for new treatments as resistance continues to rise.

In China, the usage of antibiotics for MDR-GNB infections has increased significantly, highlighting the urgent need for effective new therapies. MRX-8’s promising safety and efficacy profile could address a critical gap in the current treatment options, offering new hope to patients and reducing the burden on healthcare systems.

The development of MRX-8 addresses the urgent need for effective treatments for multidrug-resistant Gram-negative bacterial infections, aiming to overcome the limitations of current therapies.



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