Shanghai MicuRx Pharmaceuticals has announced the successful conclusion of the Phase I clinical trial of its antibacterial drug MRX-8 in China, meeting the expected goals.
A new injectable polymyxin antibacterial agent, MRX-8 is intended for treating infections caused by multi-drug-resistant Gram-negative bacteria.
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The double-blind, randomised, placebo-controlled study, including single ascending dose and multiple ascending dose components, aimed to assess the drug’s safety, tolerability, and pharmacokinetics in healthy Chinese adults.
According to the findings, the drug exposure of MRX-8 in the human body was found to be dose-proportional.
At the expected clinical dose of 2.5mg/kg once daily, MRX-8 demonstrated the potential for the best therapeutic effects against resistant infections.
Throughout the trial, MRX-8 showed a good safety profile, without any participants withdrawing due to adverse events and no severe adverse events were reported.
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By GlobalDataMild sensory reduction and reduced glomerular filtration rate were the most common adverse events seen in the trial, which resolved without needing any intervention.
Only two participants in the multiple-dose portion experienced CTCAE Grade 2 adverse events related to the injection site.
MicuRx plans to integrate findings from both US and China Phase I trials to advance MRX-8’s clinical development.
The company is actively exploring development pathways for various indications, aiming to deliver a new antibacterial drug for treating infections caused by multidrug-resistant Gram-negative bacteria.
According to the data from a Phase I trial completed in the US in 2022, MRX-8 demonstrated to attain ideal therapeutic effects against infections caused by multidrug-resistant Gram-negative bacteria such as Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumannii.
