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news.MicuRx Pharmaceuticals has reported positive top-line results from the first Phase II clinical trial for its lead drug MRX-I, an oral oxazolidinone antibiotic designed to treat drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE).
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According to the company, MRX-I is claimed to offer physicians and patients a safer and better tolerated therapeutic option compared to the currently available oxazolidinone agents.
MicuRx Pharmaceuticals president and CEO Dr Zhengyu Yuan said: "These clinical data demonstrate that MRX-I has the potential to be a safe and effective antibiotic for a broad range of infections, including those that are multidrug-resistant."
The double-blind trial was carried out at 29 sites in China, in which patients with complicated skin and soft tissue infections received either 600mg or 800mg of MRX-I, or 600mg of linezolid, twice daily for a period of up to 14 days.
The company said that of 199 patients with confirmed or suspected Gram-positive bacterial infection at the time of admission, 178 patients were clinically evaluable at the test-of-cure (TOC) visit.
For the clinically evaluable patients, the clinical cure rates at the TOC visit were comparable for the MRX-I 800 mg group (96.5%) and the linezolid group (95.5%), the company said.
Both doses of MRX-I showed a favorable safety and tolerability profile and there were no drug-related serious adverse events noted in patients receiving either MRX-I or linezolid.
Fudan University Institute of Antibiotics director and the principle investigator of this study Dr Yingyuan Zhang said: "The oxazolidinone class of antibiotics stands out from others with a remarkably low propensity for bacterial resistance.
"However, these antibiotics typically come with the myelosuppression adverse event, which limits its use.
"Data from the Phase II study of MRX-I reported today combined with prior Phase I trial results indicate that this promising agent may offer the efficacy of the oxazolidinone class without bone marrow toxicity.
"Adding to our body of clinical knowledge, we have completed dosing in a second Phase II trial conducted in the US, and results will be available in the fourth quarter of 2015. The full data set for MRX-I will inform the design of our planned Phase III clinical trials."