MicuRx Initiates Phase 3 Clinical Trial for MRX-I, A New Potent Oral Antibiotic Against Gram-positive Bacteria, Including MRSA
HAYWARD, Calif. and SHANGHAI, Oct. 20, 2016 /PRNewswire/ -- MicuRx Pharmaceuticals, Inc. announced today that it has initiated patient enrollment in a pivotal Phase 3 study of MRX-I in China for the treatment of complicated skin and skin structure infections (cSSSI). These infections are frequently 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).
"The recent $55M 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 U.S. clinical program. The initiation of this study is a significant milestone for MicuRx, as well as for the antibiotic field at large," said Zhengyu Yuan, Ph.D., president and CEO of MicuRx. "Antibiotic resistance to current therapies is at an all-time high. According to the Centers for Disease Control in the U.S., over two million people are infected with bacteria resistant to antibiotics every year and tens of thousands die annually.1 New oral treatments are desperately needed, and MRX-I may well meet this medical need."
The MicuRx Phase 3 study will enroll 600 patients with cSSSI at more than 40 centers in China. Evaluation in two randomized groups of patients will compare 800 mg of oral MRX-I to 600 mg 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 clearance of the infection and to monitor side effects. Results are expected in early 2018.
Currently, most anti-MRSA agents for serious infections are available only intravenously (IV). According to two independent market research reports based on physician surveys, an oral, anti-MRSA antibiotic that is safe for patients with co-morbidities, especially for use longer than 10 days, remains an important unmet medical need.2,3
"We are developing a better tolerated, oral antibiotic for patients and healthcare providers that will allow more convenient and affordable therapy of drug-resistant Gram-positive bacterial infections, potentially reducing hospitalization and inconvenient drug administration required for IV-only antibiotics," commented Barry Hafkin, M.D., chief medical officer of MicuRx. "With the recent policy change in China, oral antibiotics for MRSA are preferred to allow for patients to be treated in the community instead of receiving an IV in the hospital."
In 2015, MicuRx successfully completed two independent Phase 2 studies for MRX-I in China and the U.S. Both Phase 2 trials, as well as completed Phase 1 studies in China, Australia, and the U.S. demonstrated that MRX-I is highly efficacious with non-inferiority to linezolid in treatment of skin infections, and with markedly-reduced hematologic toxicity compared to oral linezolid.
About Methicillin-Resistant Staphylococcus Aureus (MRSA)
MRSA is the world's most common 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. While several antibiotics with activity against MRSA are marketed, very few oral agents against this pathogen are available. New oral treatment options with an improved safety profile are needed for the outpatient therapy, as well as for broadly preferred transition from intravenous to oral therapy providing maximum convenience to patients and minimizing the hospitalization time and cost.
About MicuRx Pharmaceuticals, Inc.
MicuRx (http://www.micurx.com/) is a privately-held biopharmaceutical company whose mission is to discover and develop antibiotics with improved safety profiles to improve the treatment of resistant bacterial infections. The lead compound, MRX-I, a next-generation oxazolidinone targeting methicillin resistant S. aureus (MRSA), was structure-designed to reduce hematological adverse events of this antibiotic class. In 2015, MicuRx completed two independent Phase 2 studies in the US and China for MRX-I, and has initiated Phase 3 in China in complicated skin and skin structure infections (cSSSI). The company has research and development facilities outside San Francisco, CA in the United States, and in Shanghai, China. The company has raised a total of $92 million through leading venture capital firms including Morningside Ventures, BVCF, GP Healthcare Capital, GP TMT Capital, 3E Bioventures Capital, and Delian Capital. Visit www.micurx.com for more information.
- Antibiotic Resistance Threats Report, 2013. Centers for Disease Control and Prevention, https://www.cdc.gov/drugresistance/
- Disease Landscape & Forecast, Methicillin-Resistant Staphylococcus Aureus'. January 2016. Report by Decision Resource Group
- BioTrak Research, Quantitative Market Study with US Infectious Disease Physicians, 2016
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SOURCE MicuRx Pharmaceuticals, Inc.