Emergent BioSolutions today announced that it has acquired the lead broad-spectrum antibiotic candidate, currently receiving Defense Threat Reduction Agency (DTRA) development funding, from Evolva Holding SA.
The oral and IV treatment for Burkholderia pseudomallei as well as other bioterror agents is EV-035, a series of novel small molecule broad spectrum antibiotics of the 4-oxoquinolizine class and targets bacterial type IIa topoisomerase.
The lead molecule in the series, GC-072, has demonstrated protection in vivo from lethal B. pseudomallei infection when administered orally. GC-072 is being developed as a potential oral and IV treatment for B. pseudomallei under a three-year, $15 million contract with DTRA.
B. pseudomallei is a gram-negative pathogen classified by the Centers for Disease Control and Prevention as a Category B bioterrorism agent and a priority threat capable of being easily weaponized and disseminated.
“Emergent’s acquisition of the EV-035 series of broad spectrum antibiotics further aligns us with the U.S. government’s strategic objective of combating antibiotic-resistant bacteria, which the Administration considers a national security priority that requires continued development funding,” said Adam Havey, executive vice president and president, biodefense division of Emergent BioSolutions.
In vitro models have shown activity of the EV-035 series of molecules in gram-negative and gram-positive bacteria, including multi-drug resistant and quinolone-resistant bacteria (e.g., Escherichia coli, Acinetobacter baumannii, Staphylococcus aureus [including methicillin-resistant S. aureus or MRSA], Streptococcus pneumoniae, Enterococcus faecalis, Pseudomonas aeruginosa, and Haemophilus influenzae) and biodefense pathogens (e.g., Burkholderia pseudomallei, Bacillus anthracis, Francisella Tularensis, and Yersinia pestis).
The scope of the DTRA contract includes investigating GC-072 as a treatment for B. pseudomallei in preclinical in vitro and in vivo studies, conducting formulation, manufacturing and toxicology studies, exploring efficacy in additional multi-drug resistant biodefense and commercial pathogens, and preparing an Investigational New Drug application for submission to the U.S. Food and Drug Administration.