MicuRx Pharmaceuticals, a privately-held biopharmaceutical company developing next-generation antibiotics, announced that it has received the approval from the US Food and Drug Administration (FDA) to initiate phase 2 clinical study in the United States for its lead drug candidate MRX-I. MRX-I, which demonstrated an enhanced safety profile over the market-leading comparator in phase 1 studies, is an oral oxazolidinone antibiotic designed to treat infections caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).
The phase 2 double-blind, multi-center, active comparator-controlled clinical trial will enroll over 120 patients with acute bacterial skin and skin structure infections (ABSSSI) at multiple centers in the United States. Patients will be randomized to receive MRX-I or Zyvox for a treatment period of up to ten days.
"We are pleased to initiate phase 2 clinical trial in the United States. This complements the ongoing phase 2 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," says Zhengyu Yuan, president and chief executive officer, of MicuRx Pharmaceuticals, Inc. "This dual-country approach will allow MicuRx to maximize the commercial potential of MRX-I both in the US and China."
Data from two phase 1 studies 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. Phase 2 study in China is scheduled for completion in mid-2015.
"This is an exciting moment for the company," commented Dr. James Ge, MD, executive vice president and chief operating and development officer of MicuRx. "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."