GlaxoSmithKline has been awarded an initial $38.5 million in Biomedical Advanced Research and Development Authority (BARDA) funding to support the ongoing clinical development of its boron-based Gram-negative systemic antibiotic GSK ‘052 for both bioterrorism and public health applications.
The BARDA contract is for an initial two years, but could be extended for a further two years, with an additional $55.5 million in funding. BARDA will provide technical as well as financial support to the program. The funding will back studies evaluating GSK ‘052 against bioterrorism threats such as plague or tularemia, along with Phase II clinical trials in patients with ventilator-associated pneumonia (VAP), and Phase III studies in patients with complicated intra-abdominal infections (cIAI). GSK has been developing the drug for the VAP and cIAI indication, and against complicated urinary tract infections (cUTI). Phase IIb studies are ongoing for the cUTI and cIAI indications.
The BARDA contract will in addition support laboratory testing of GSK ‘052 against multidrug-resistant pathogens, including those containing the New Delhi Metallo-beta-lactamase-1 (NDM-1) gene, which are resistant to almost all routine antibiotics, BARDA notes.
The award is the third signed as part of the authority’s Broad Spectrum Antimicrobials Program, which has been established as a result of a review of medical countermeasures requested by the U.S. Department of Health and Human Services last year. The antimicrobials initiative aims to develop broad spectrum medical countermeasures against biological threat agents, which can also be used to address common public health issues such as multidrug-resistant infections.
“This commercial-plus- biodefense strategy creates a sustainable, cost-effective business model for private industry and taxpayers, and it promotes a warm base manufacturing capability for use in a public health emergency,” comments BARDA director Robin Robinson, Ph.D.
GSK ’052 was originally developed by Anacor, and licensed to the U.K.-based drugs firm in July 2010 as part of an ongoing R&D collaboration. The drug is a boron-based systemic antibiotic that targets the bacterial leucyl-transfer RNA synthetase (leuRS) enzyme required for protein synthesis. GSK says that as there are no commercially available antibiotics that target leuRS, there is no known pre-existing bacterial resistance.