14 September 2017 - - US-based antibiotic developer Geom Therapeutics, Inc. has signed a clinical trial agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to conduct a Phase I study with GT-1, a cephalosporin antibiotic with a novel uptake mechanism and broad-spectrum activity against Gram-negative bacteria, including multidrug-resistant (MDR) Pseudomonas aeruginosa and Acinetobacter species, the company said.
GT-1 has demonstrated excellent in vitro and in vivo activity against pathogens that have been identified by the World Health Organization as priority pathogens, including Acinetobacter spp. and P. aeruginosa, which can cause severe and often deadly infections, such as bloodstream infections and pneumonia.
Under the agreement between NIAID and Geom Therapeutics, the NIAID-supported Phase I clinical trial units for therapeutics plans to conduct a double-blind, placebo-controlled, dose-escalating study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of GT-1 in healthy volunteers.
This trial will be conducted at Duke University.
GT-1 is a novel siderophore cephalosporin antibiotic and is being developed for the treatment of MDR Gram-negative bacterial infections that is actively transported into Gram-negative cells by exploiting iron uptake systems that use low molecular weight iron-binding molecules, known as siderophores, to transport iron into the cells.
This strategy facilitates the uptake of GT-1 into the bacterial periplasmic space in high concentrations where GT-1 binds to its penicillin-binding protein targets and disrupts cell wall synthesis, leading to cell death. The increased transportation into bacterial cells potentiates activity against Gram-negative bacteria, including activity against MDR Acinetobacter spp. and P. aeruginosa.
All IND-enabling studies have been completed for GT-1 and Geom Therapeutics plans to submit an IND to the FDA in 2H 2017.
Geom Therapeutics, a biotechnology company focused on the development of novel antibiotics for MDR Gram-negative infections, is a joint venture with LegoChem Biosciences, a publicly traded Korean biotechnology Company (KOSDAQ: 141080) and the inventor of GT-1.
NIAID conducts and supports research to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.