MicuRx begins Phase I trial of MRX-4 against Gram-positive bacteria
US-based biopharmaceutical company MicuRx has begun its Phase I clinical trial of MRX-4, for the treatment of infections caused by Gram-positive bacteria, including methicillin-resistant S. aureus (MRSA) and vancomycin-resistant Enterococci (VRE).
MRX-4 is a prodrug version of the oral antibiotic MRX-1, an oxazolidinone agent. MRX-4 is suited for both intravenous and enhanced oral applications.
The drug is currently being evaluated within Phase III clinical trials in China for the treatment of complicated skin infections.
The Phase I trial is being conducted to assess the safety and tolerability, as well as determine the pharmacokinetics profile and bioavailability of the oral formulation of MRX-4.
MicuRx has started enrolling patients at a single centre in the US and is planning to enrol 122 healthy subjects in nine single and four multiple-ascending dose cohorts.
The company will concurrently evaluate the safety, tolerability, and pharmacokinetics of the intravenous formulation of MRX-4 while examining 60 healthy subjects of five single-ascending and four multiple-ascending dose cohorts, along with an oral to IV crossover study.
MicuRx chief medical officer Barry Hafkin said: "An oral anti-MRSA agent like MRX-4 with a safety profile appropriate for outpatients and for extended treatment remains an unmet medical need despite recent antibiotic launches.
"In addition, an IV formulation of the same molecule is highly desirable to allow physicians to treat serious MRSA or VRE infections in hospital, before transitioning to an oral outpatient treatment."