According to PRNewswire, on August 13, 2020, MicuRx Pharmaceuticals Inc. announced that the global partnership Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has committed up to US$7.78 million of nondilutive financing for a Phase 1 clinical trial and related R&D activities of its new antimicrobial agent MRX-8. Previously, CARB-X has funded investigational new drug (IND) enabling studies for MRX-8 in the US.
MicuRx also announced that the FDA has completed review of the IND application for MRX-8 and gave clearance for the first-in-human clinical trial to proceed. The CARB-X funding will be used to support the Phase 1 trial, as well as activities essential for future Phase 2 clinical trials.
MRX-8 is a novel polymyxin active against infections caused by multidrug-resistant (MDR) Gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii. Its potent antimicrobial coverage is characteristic of this prominent antibiotic class represented by the current drugs colistin and polymyxin B (PMB). The new agent is beneficially differentiated by its minimized nephrological and neurological toxicities. Nephrotoxicity manifests as acute kidney injury, occurring with an incidence of up to 60% in patients treated with colistin and PMB, relegating the current polymyxins to a last-resort therapeutic option.
"We are very grateful to collaborate with CARB-X in addressing the global need for safer and more effective antibiotics, and appreciate the generous financial and technical support from this non-profit partnership comprised of prominent funding institutions and leaders in the R&D of antibacterials," stated Zhengyu Yuan, PhD, President and CEO of MicuRx.
MRX-8 was discovered by MicuRx scientists and the company owns worldwide IP rights to its composition and use. This innovative agent has advanced from the original concept through a successful US IND application, and towards the first-in-human Phase 1 study. This progress underscores the MicuRx commitment to develop innovative antibiotics against resistant bacterial pathogens. The new drug candidate MRX-8 compliments NDA-track agent contezolid and Phase 2 agent contezolid acefosamil, to establish a complete line of MicuRx products for therapies of serious Gram-negative and Gram-positive bacterial infections.
About MicuRx
MicuRx is a privately held biopharmaceutical company focusing on discovering and developing antibiotics with improved safety profiles to treat resistant bacterial infections. The company has research and development facilities outside San Francisco, CA, in the United States, and in Shanghai, China.
About CARB-X
CARB-X is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is investing up to $500 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, and rapid diagnostics.
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