MicuRx Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) to begin Phase II clinical trial in the US for MRX-I, an oral oxazolidinone antibiotic designed to treat infections caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).
In Phase I trials, the company’s lead drug candidate MRX-I has showed an improved safety profile over its comparator Zyvox.
The double-blind, multi-centre, active comparator-controlled Phase II clinical trial will enrol more than 120 patients with acute bacterial skin and skin structure infections (ABSSSI) at multiple centers in the US.
During the trial, patients will be randomised to receive MRX-I or Zyvox for a treatment period of up to ten days.
MicuRx Pharmaceuticals president and CEO Zhengyu Yuan said: "We are pleased to initiate Phase II clinical trial in the US.
"This complements the ongoing Phase II study of MRX-I in China and represents a significant milestone in our global development strategy, as MicuRx creates new antibiotics to address urgent medical needs.
"This dual-country approach will allow MicuRx to maximise the commercial potential of MRX-I both in the US and China."
The company said that data from two Phase I trials in China and Australia have confirmed that MRX-I was safe and well tolerated in healthy volunteers at all dose regimens, including 28-day repeated dosing regimen alongside Zyvox comparator, with no evidence of myelosuppression which is typical for this class.
The ongoing Phase II trial of MRX-I in China is scheduled to be completed in mid-2015.
MicuRx executive vice-president and chief operating and development officer Dr James Ge said: "With its favourable profile, MRX-I has the potential to be a safer option to effectively treat severe infections caused by drug resistant gram-positive bacteria.
"We are looking forward to positive outcome from these trials within a year, and the subsequent initiation of pivotal studies that will support concurrent drug registration in both the United States and China."
The company is focused on discovering and developing new antibiotics to combat infections due to drug-resistant bacteria.