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Antabio Receives QIDP Designation from the U.S. FDA for the Development of MEM-ANT3310, a Novel Broad-Spectrum Combination Therapy Targeting WHO’s Priority Pathogens

  • QIDP is granted to Antabio’s MEM-ANT3310 for major hospital indications including nosocomial pneumonia

Labège, France, May 6th, 2020. Antabio SAS, the biopharmaceutical company focused on developing a broad pipeline of antibacterial treatments against life threatening WHO critical priority pathogens, announced today that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to Antabio’s MEM-ANT3310, a combination of meropenem (MEM) and the novel broad-spectrum serine beta-lactamase inhibitor ANT3310. QIDP was granted to MEM-ANT3310 for the treatment of complicated urinary tract infections (cUTI), hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP) and complicated intra-abdominal infections (cIAI).

ANT3310 is a novel, potent and specific inhibitor of bacterial Serine Beta-Lactamases (SBLs) currently in preclinical development, which displays excellent inhibitory activity against both KPC and OXA carbapenemases. It will be administered intravenously in conjunction with meropenem, for treating hospital-acquired infections caused by Gram negative pathogens, including those that are carbapenem-resistant, notably carbapenem-resistant Enterobacteriaceae (CRE) and carbapenem-resistant A. baumannii (CRAB), which are WHO Priority Pathogens. CRAB is spreading worldwide, accounting for more than 70% of A. baumannii in many countries, and it is one of the most common causes of hospital-acquired respiratory infections.

ANT3310 potentiates meropenem activity against CRAB in murine infection models and restores meropenem susceptibility in 95% of A. baumannii clinical isolates. By targeting both CRE and CRAB, as well as covering most P. aeruginosa strains, the MEM-ANT3310 combination is clearly differentiated from other β-lactam/β-lactamase inhibitor (BL/BLI) combinations in its broad activity against key multi-drug resistant Gram-negative pathogens commonly encountered in nosocomial infections. The ANT3310 program is in preclinical development. […]

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