MicuRx Pharmaceuticals announced 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.
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An improved renal safety of MRX-8 was established in multiple preclinical tests, including toxicity studies in nonhuman primates. Furthermore, MRX-8 has exhibited superior efficacy to PMB in certain nonclinical models of Gram-negative infections, such as urinary tract and lung infection animal models.
"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," said Zhengyu Yuan, PhD, President and CEO of MicuRx.