HAYWARD, California and SHANGHAI, March 5, 2018 /PRNewswire/ -- MicuRx Pharmaceuticals, Inc. today announced that the global partnership Combating Antibiotic Resistant Bacteria Accelerator (CARB-X) has committed up to $5.2 million of non-dilutive financing for IND enablement and subsequent Phase 1 clinical studies of MRX-8, also known as PMX-8. This agent is a novel polymyxin antibiotic designed to treat multi-drug resistant Gram-negative infections such as E. coli, P. aeruginosa, K. pneumoniae and A. baumannii.
The antibacterial class of polymyxins includes the drugs colistin and polymyxin B, essential antibiotics with potent activity against Gram-negative pathogens. While very effective, polymyxins are relegated to a last-resort option due to the high incidence of kidney toxicity (nephrotoxicity), with rates up to 60% for the current polymyxin therapy. In addition to nephrotoxicity, polymyxins can manifest neurotoxicity. Due to the lack of agents effective against multi-drug resistant infections, physicians are increasingly using polymyxins, despite the toxicity. Importantly, no novel systemic polymyxin has been approved in over 60 years.
The new agent MRX-8 is designed to overcome the limiting nephrotoxicity of current polymyxins. Current preclinical data demonstrated its high efficacy, with the reduced nephrotoxicity as well as attenuated acute or neuromuscular toxicity, when compared to existing polymyxin drugs.
"We are pleased to have received this support for our MRX-8 program from CARB-X, a non-profit partnership comprised of the key global leaders in the science, development, and the medical use of anti-infectives," stated Zhengyu Yuan, Ph.D., president and CEO of MicuRx.
CARB-X was created in response to the U.S. government's 2015 National Action Plan for Combating Antibiotic Resistant Bacteria (CARB) and the UK government's call in 2016 for a concerted global effort to tackle antibiotic resistance. CARB-X was launched by the U.S. Department of Health and Human Services (HHS)'s Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID/NIH). Funders are BARDA and Wellcome Trust.
"The MicuRx team is excited to rapidly advance MRX-8 from the original concept and into IND development, with the opportunity to augment the armamentarium of effective antibiotics urgently needed to treat serious Gram-negative infections," stated Mike Gordeev, Ph.D., CSO of MicuRx.
About Multidrug-Resistant Gram-negative Infections
Gram-negative infections represent a growing global health threat inadequately addressed with current antibiotics. Gram-negative pathogens such as E. coli, K. pneumoniae, A. baumannii, P. aeruginosa, and Enterobacter bacterial species are the leading cause of serious hospital-acquired infections. These infections represent unmet medical need requiring global R&D efforts to create novel more effective pharmaceuticals. Gram-negative pathogens cause a wide variety of infections, including urinary tract, lung, muscle, bone, and blood diseases. Development of drugs against Gram-negative pathogens is particularly challenging due to a unique cell-wall structure incorporating a protective outer membrane, absent in Gram-positive bacteria, along with diverse mechanisms of acquiring the bacterial resistance to antibiotics.
These critical attributes of Gram-negative pathogens render majority of the current agents ineffective. For example, no single antibiotic is effective in therapy of serious infections due to multiple drug-resistant (MDR) P. aeruginosa, K. pneumoniae, E. coli, or A. baumannii. Therapeutic failure rates for such infections often exceed 40 percent, particularly in elderly and infant patients.
About CARB-X
CARB-X is the world's largest public-private partnership devoted to early stage antibacterial R&D. Funded by ASPR/BARDA and Wellcome Trust, with in-kind support from NIAID, CARB-X is investing up to $455 million from 2016-2021 to support innovative products from 'hit-to-lead' phase through Phase 1 clinical trials. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X operates through Boston University. Other partners include RTI International, the Broad Institute of Harvard and MIT, MassBio, and the California Life Sciences Institute (CLSI). www.carb-x.org.
This press release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust. The contents are solely the responsibility of the authors and do not necessarily represent the official views of CARB-X, the HHS Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health or Wellcome Trust.
About MicuRx Pharmaceuticals, Inc.
MicuRx is a privately-held biopharmaceutical company whose mission is to discover and develop effective antibiotics with improved safety to enhance the treatment of serious bacterial infections. Its lead compound, MRX-1 is a next-generation oxazolidinone targeting Gram-positive infections, such as methicillin-resistant S. aureus (MRSA). The agent is designed to reduce hematological adverse events of this antibiotic class. MicuRx has completed two independent Phase 2 studies in the US and China for MRX-1 in 2015 and initiated a Phase 3 study in China in 2016 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 $100 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.