HAYWARD, Calif. and SHANGHAI, Nov. 30, 2016 /PRNewswire/ -- MicuRx Pharmaceuticals, Inc. today announced the start of a Phase 1 clinical trial of a new antimicrobial agent, MRX-4, for the treatment of infections caused by Gram-positive bacteria including methicillin-resistant S. aureus (MRSA) and vancomycin-resistant Enterococci (VRE). MRX-4 is a prodrug form of the oral antibiotic MRX-1, presently in Phase 3 clinical trials in China for the treatment of complicated skin infections.
This comprehensive Phase 1 trial, now enrolling patients at a single center in the United States, will evaluate safety, tolerability, pharmacokinetics and bioavailability of the oral formulation of MRX-4. The study will enroll 122 healthy subjects in nine single and four multiple-ascending dose cohorts. Concurrently, the safety, tolerability, and pharmacokinetics of the intravenous formulation of MRX-4 will be evaluated in 60 healthy subjects of five single- and four multiple-ascending dose cohorts, along with an oral to IV crossover study.
"We anticipate that success in this Phase 1 trial would enable a rapid transition into advanced clinical studies in the U.S. for this new means of efficient delivery of our antibiotic systemically," stated Zhengyu Yuan, Ph.D., president and CEO of MicuRx.
MRX-1 is a next-generation oxazolidinone agent that has shown notably improved hematopoietic safety compared to first-generation antibiotics, such as linezolid, while maintaining excellent efficacy characteristics for this class. The prodrug form of MRX-1, named MRX-4, serves to expand its utility into both intravenous and enhanced oral applications.
"An oral anti-MRSA agent like MRX-4 with a safety profile appropriate for outpatients and for extended treatment remains an unmet medical need despite recent antibiotic launches," emphasized Barry Hafkin, M.D., chief medical officer of MicuRx. "In addition, an IV formulation of the same molecule is highly desirable to allow physicians to treat serious MRSA or VRE infections in hospital, before transitioning to an oral outpatient treatment."
"Discovered at MicuRx, MRX-4 represents a novel class of water-soluble prodrugs inspired by ubiquitous structures common in nature," added Mike Gordeev, Ph.D., chief scientific officer of MicuRx. "The U.S. patent for this entity has been issued, and we are pleased to see its successful entry into clinical trials."
About Methicillin-Resistant Staphylococcus Aureus (MRSA)
MRSA is the world's most common human 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 serious infections are available. New oral treatment options with 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 minimize 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-1, 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-1, and in 2016 initiated a Phase 3 study in China for the treatment of 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.
Advertisement
This comprehensive Phase 1 trial, now enrolling patients at a single center in the United States, will evaluate safety, tolerability, pharmacokinetics and bioavailability of the oral formulation of MRX-4. The study will enroll 122 healthy subjects in nine single and four multiple-ascending dose cohorts. Concurrently, the safety, tolerability, and pharmacokinetics of the intravenous formulation of MRX-4 will be evaluated in 60 healthy subjects of five single- and four multiple-ascending dose cohorts, along with an oral to IV crossover study.
Advertisement
"We anticipate that success in this Phase 1 trial would enable a rapid transition into advanced clinical studies in the U.S. for this new means of efficient delivery of our antibiotic systemically," stated Zhengyu Yuan, Ph.D., president and CEO of MicuRx.
MRX-1 is a next-generation oxazolidinone agent that has shown notably improved hematopoietic safety compared to first-generation antibiotics, such as linezolid, while maintaining excellent efficacy characteristics for this class. The prodrug form of MRX-1, named MRX-4, serves to expand its utility into both intravenous and enhanced oral applications.
"An oral anti-MRSA agent like MRX-4 with a safety profile appropriate for outpatients and for extended treatment remains an unmet medical need despite recent antibiotic launches," emphasized Barry Hafkin, M.D., chief medical officer of MicuRx. "In addition, an IV formulation of the same molecule is highly desirable to allow physicians to treat serious MRSA or VRE infections in hospital, before transitioning to an oral outpatient treatment."
"Discovered at MicuRx, MRX-4 represents a novel class of water-soluble prodrugs inspired by ubiquitous structures common in nature," added Mike Gordeev, Ph.D., chief scientific officer of MicuRx. "The U.S. patent for this entity has been issued, and we are pleased to see its successful entry into clinical trials."
About Methicillin-Resistant Staphylococcus Aureus (MRSA)
MRSA is the world's most common human 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 serious infections are available. New oral treatment options with 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 minimize 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-1, 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-1, and in 2016 initiated a Phase 3 study in China for the treatment of 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.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/micurx-initiates-phase-1-clinical-trial-in-us-for-novel-antibiotic-agent-mrx-4-300369808.html
SOURCE MicuRx Pharmaceuticals, Inc.
