MICURX REPORTS POSITIVE TOP-LINE RESULTS OF A CHINA PHASE 3 CLINICAL TRIAL FOR NOVEL ANTIBIOTIC CONTEZOLID IN COMPLICATED SKIN AND SOFT TISSUE INFECTIONS
Time:2019-09-19 / View:47 times
SHANGHAI, China, and FOSTER CITY, California, USA – September 19, 2019. MicuRx Pharmaceuticals, Inc., today announced positive top-line results from the pivotal Phase 3 clinical trial in China for its lead antibacterial drug candidate contezolid (MRX-I) in adult patients with complicated skin and soft tissue infection (cSSTI). Contezolid met the primary endpoint of noninferiority compared to linezolid for the clinical cure rate at the test-of-cure visit, and was associated with fewer drug-related hematologic laboratory adverse events.
“We are very pleased with the favorable results of this Phase 3 clinical trial which established that contezolid is an effective and safer antibacterial drug,” said Dr. Zhengyu Yuan, President and CEO of MicuRx. “We plan to file a New Drug Application with the National Medical Products Administration (NMPA) of China in the 4th quarter of 2019 for this exciting new drug,” continued Dr. Yuan.
Contezolid is an oral oxazolidinone antibiotic designed to treat drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE), while offering physicians and patients a new therapeutic option than currently available oxazolidinone agents. The development of contezolid in China has been designated as a “Significant New Drugs Development Special Project”, and contezolid has also been granted QIDP designation and Fast Track status by the US FDA. Dr. Yuan stated, “We are grateful for the participation of all the patients in this study, as well as the investigators, and I look forward to presenting more data from this pivotal Phase 3 study on September 21, 2019, at the China BioMed Innovation and Investment Conference in Suzhou.” About MicuRx Pharmaceuticals, Inc.
MicuRx Pharmaceuticals (http://www.micurx.com/) is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of antimicrobial therapeutics for multidrug-resistant (“MDR”) “superbug” infections. Since our inception in 2007, we have built a pipeline that includes contezolid (MRX-I), contezolid acefosamil (MRX-4), MRX-8 (novel polymyxin MDR Gram-negative agent), and MRX-12 (new class MDR Gram-negative agents). Our mission is to combat pathogens on the WHO list of “superbugs”. Our lead compound, contezolid (MRX-I), a next-generation oxazolidinone, was structure-designed to reduce the hematologic toxicity and monoamine oxidase inhibition risk of this antibiotic class. Contezolid acefosamil (MRX-4) is a prodrug of contezolid and is planned to advance into global Phase 3 development in battling MDR Gram-positive infections with both oral and IV formulations. MicuRx has R&D centers outside of San Francisco, California, and in Shanghai, China. The company has raised a total of US$107 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.