-- Clinical Completion of Phase 1 Trials for Novel Oral/Injectable Antibiotic Contezolid Acefosamil (MRX-4) --
HAYWARD, Calif. and SHANGHAI, Dec. 7, 2017 /PRNewswire/ -- MicuRx Pharmaceuticals, Inc. today announced closing of ¥100 million private financing led by Chinese affiliates of the existing MicuRx investors Delian Capital and BVCF. Funds will support completion of the ongoing Phase 3 program for its oral antibiotic, contezolid (MRX-I) as well as the projected Chinese NDA filing, along with other business activities in China.
MicuRx also announced the clinical completion of Phase 1 studies for both the oral and the intravenous formulations of contezolid acefosamil (MRX-4), a water-soluble prodrug of contezolid. Contezolid acefosamil is being developed for the treatment of serious infections caused by Gram positive bacteria, including methicillin-resistant S. aureus (MRSA) and vancomycin-resistant Enterococci (VRE).
Single- and multiple-ascending dose Phase 1 studies of contezolid acefosamil were conducted at a single center in the United States, with 130 and 80 healthy subjects enrolled for oral and injectable cohorts, respectively. Contezolid acefosamil was safe and well tolerated at all doses tested, including doses well in excess of that required for efficacy in the treatment of serious infections, and with favorable pharmacokinetics resulting in good exposure systemically in the plasma and urine. No safety signals were detected in any single- or multiple-dose cohorts per routine laboratory results, including serum chemistry, hematology, and urinalysis, and no ECG or vital sign safety signals were observed.
"We are thrilled to meet the high expectations for clinical performance of contezolid acefosamil. With this additional funding provided by our long-standing investors and their affiliates, we are quickly advancing our clinical development programs both in the USA and China," stated Zhengyu Yuan, Ph.D., president and CEO of MicuRx.
Contezolid and its prodrug contezolid acefosamil are next-generation oxazolidinone agents with notably improved hematopoietic safety compared to earlier antibiotics of this class, such as linezolid, while maintaining excellent therapeutic efficacy of the latter.
"Despite recent antibiotic launches, unmet needs still exist for an oral anti-MRSA agent with a safety profile appropriate for outpatients and for extended treatment, like contezolid," declared Barry Hafkin, M.D., MicuRx chief medical officer. "The flexibility of having both intravenous and oral formulations of the same antibiotic agent is highly desirable to allow physicians to treat serious MRSA or VRE infections in the hospital, before transitioning to oral outpatient treatment. We believe contezolid acefosamil has the potential to meet these unmet medical needs."
About Methicillin-Resistant Staphylococcus Aureus (MRSA)
MRSA is the world's most common human bacterial pathogen, responsible for millions of infections in the skin, bone, lung and bloodstream, and results in tens of thousands of deaths worldwide annually. While several antibiotics with activity against MRSA are marketed, very few oral agents against serious infections are available. New oral treatment options with an improved safety profile are needed for the outpatient therapy, as well as for the preferred transition from intravenous to oral therapy providing maximum convenience to patients and minimizing 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 compounds, contezolid (MRX-1) and contezolid acefosamil (MRX-4), next-generation oxazolidinones targeting methicillin resistant S. aureus (MRSA), were 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 oral contezolid (MRX-1), and is currently nearing completion of the Phase 3 program in China for the treatment of complicated skin and skin structure infections (cSSSI). Contezolid acefosamil (MRX-4) phase 2 study in the USA is expected to start in 2018. The company has research and development facilities outside San Francisco, CA in the United States, and in Shanghai, China. MicuRx has raised a total of $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.