CARB-X funds GSK to develop a new drug for urinary tract infections (UTI) caused by Escherichia coli bacteria
CARB-X announced today it is awarding up to US$7.51 million to GlaxoSmithKline (NYSE: GSK), to develop a new drug to treat and prevent recurrent urinary tract infections (UTIs) caused by the Escherichiacoli(E. coli) bacteria.
“Serious bacterial infections are a global health threat, due in part to the emergence of drug-resistant bacteria for which we do not have therapies,” said Erin Duffy, CARB-X R&D Chief. “GSK’s project is in the early stages of development, and if successful, could potentially treat and prevent recurrent UTIs caused by E. coliand stop harmful bacteria from spreading in the body.”
UTIs are among the most frequent bacterial infections. UTIs occur when bacteria from the skin or periurethral area enter the urethra and infect the urinary tract and bladder. More women than men develop these infections, at a ratio of 8:1. An estimated 40-50 per cent of women will develop a UTI in their lifetime.
Most uncomplicated UTIs are caused by E. coli. Antibiotic resistance in E. coli is of particular concern because it is the most common Gram-negative pathogen in humans. Antibiotic resistance rates in E. coli are rapidly rising, especially with regard to fluoroquinolones and third- and fourth-generation cephalosporins. Many multidrug-resistant strains of the bacteria are found in the community, for example in the food supply.
Innovative approach to address the rise of drug resistance
GSK’s orally bioavailable small molecule drug, GSK3882347, targets an adhesive protein found on the surface of E. colibacteria called FimH. Binding of GSK3882347 to FimH prevents E. coli from binding to the bladder wall, thereby preventing infection. With CARB-X support, the project aims to explore the safety, tolerability and pharmacokinetics of the FimH antagonist in a First Time in Human Phase 1 study which was initiated in September 2020 and is planned to be completed in 2021. The support also facilitates scale-up of the drug for future clinical and non-clinical studies.
“This CARB-X support will advance an innovative molecule that has the potential to change the way resistant bacterial infections are treated,” said John Lepore, SVP, Head of Research, GSK. “This Phase 1 study joins GSK’s other existing antibacterial programs – now numbering more than 20 active projects targeting the prevention and treatment of important pathogens — and represents our commitment to finding new and different ways to tackle antimicrobial resistance.”
Antibacterial drug development is a long and costly high-risk process. According to industry estimates, it can take more than 14 years and typically costs more than $1.5 billion to discover and develop a new medicine, and to do all the research necessary for a medicine to be approved by regulatory agencies for use in patients. At a time when most major pharmaceutical companies have moved away from antibiotic research, GSK has continued to invest in antibacterial R&D and potential new medicines.