MicuRx Pharmaceuticals has begun patient enrolment in a Phase 3 study of MRX-I in China for the treatment of complicated skin and skin structure infections (cSSSI).
These infections are usually caused by multi-drug resistant, Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
MRX-I is an oral, next-generation oxazolidinone antibacterial targeting infections due to drug-resistant, Gram-positive bacteria, including MRSA and vancomycin-resistant enterococci (VRE).
MicuRx president and CEO Zhengyu Yuan said: "The recent $55 million Series C financing will allow MicuRx to complete this Phase 3 study and file a new drug application for MRX-I in China, in addition to clinical milestones in the complementary US clinical programme.
"The initiation of this study is a significant milestone for MicuRx, as well as for the antibiotic field at large."
"Antibiotic resistance to current therapies is at an all-time high. According to the Centers for Disease Control in the US, more than two million people are infected with bacteria resistant to antibiotics every year and tens of thousands die annually. New oral treatments are desperately needed, and MRX-I may well meet this medical need."
The MicuRx Phase 3 study will see the enrolment of 600 patients with cSSSI at more than 40 centres in China.
Analysis in two randomised groups of patients will compare 800mg of oral MRX-I to 600mg of oral linezolid (Zyvox).
Patients will be treated for seven to 14 days, with a follow up observation period up to 14 days to ensure they are cleared of the infection and to monitor side effects.
Results are expected in early 2018.
Most anti-MRSA agents for serious infections are currently available only intravenously (IV).
In 2015, MicuRx completed two independent Phase 2 studies for MRX-I in China and the US.
Both Phase 2 trials, as well as the completed Phase 1 studies in China, Australia, and the US, indicated that MRX-I is highly efficacious with non-inferiority to linezolid in treatment of skin infections, and markedly reduced hematologic toxicity compared to oral linezolid.
MRSA is a human drug-resistant bacterial pathogen responsible for millions of infections and tens of thousands of deaths worldwide in a wide variety of infections such as skin, bone, lung, and bloodstream.