With antimicrobial resistance growing to many first-line antibiotics, a key concern in the U.S. FDA’s approving an oral penem like Iterum Therapeutics International Ltd.’s tablet combining sulopenem etzadroxil and probenecid is that it could become a first-line, go-to drug in treating uncomplicated urinary tract infections and, possibly, more serious infections off-label.
After receiving a complete response letter from the U.S. FDA more than three years ago and conducting another phase III trial, Iterum Therapeutics plc is preparing to make its case before an advisory committee Sept. 9 for sulopenem etzadroxil/probenecid as an oral treatment option for women with uncomplicated urinary tract infections caused by specific microorganisms.
Enlivex Therapeutics Ltd. extolled the top-line “positive indication of effect and safety” from the phase II study of Allocetra in treating sepsis and sepsis shock, but the market took another view of the clinical trial. In an analysis of eligible adult patients from the cell therapy’s multicenter, randomized, placebo-controlled, dose-finding study of 120 enrolled patients, the company also reported low mortality rates.
Gram-negative bacteria require the metalloenzyme LpxC for their outer membrane biogenesis. Blacksmith Medicines Inc. has identified an LpxC inhibitor, FG-960, which has shown a robust in vitro and in vivo profile against multidrug-resistant Enterobacterales. FG-60 is currently being investigated for the treatment of urinary tract infections (UTIs).
FmlH is a bacterial adhesin of uropathogenic E. coli (UPEC) that has been shown to be up-regulated during chronic UPEC infection. Washington University scientists recently disclosed the discovery and preclinical evaluation of novel FmlH lectin antagonists as potential candidates for the treatment of chronic urinary tract infections (UTIs) and kidney infections.
At this week’s ACS meeting in New Orleans, Fimbrion Therapeutics Inc. presented the rational design of a different series of small-molecule biaryl O- and C-linked mannoside-based inhibitors of the virulence factor FimH, as potential agents for the treatment of urinary tract infections (UTIs).
Phaxiam Therapeutics SA has initiated a new preclinical development program targeting Klebsiella pneumoniae, which is responsible for severe infections and notable for its high resistance to antibiotics.
Intron Biotechnology Inc. has entered into an official contract with the U.S. Army Combat Capabilities Development Command (DEVCOM) to develop bacteriophages for combating uropathogenic Escherichia coli (UPEC) infections. DEVCOM, a subcommand of the U.S. Army Futures Command, has been working on a project to develop products that address the risk of urinary tract infections (UTIs) among soldiers exposed to austere environments, such as when deployed or undergoing training.
A new bacteriophage-based rapid test has the potential to identify the specific pathogen causing a urinary tract infection (UTI) at the point of care, enabling targeted use of antibiotics.
The test uses naturally occurring phages identified as predators of Escherichia coli, Klebsiella and Enterococci that are genetically modified to make any bacterium they invade bioluminescent.
In a proof-of-concept study, researchers at ETH Zurich, Switzerland, were able to reliably detect the pathogenic bacteria in a urine sample in less than four hours. That compares to the 18 – 30 hours it takes to culture samples in a central lab and to identify a specific microbe using conventional diagnostics.
Astek Diagnostics Inc. has wound up a successful $2 million early stage VC funding round to support the development and launch of a medical device designed for the speedy recovery of patients suffering from urinary tract infections (UTI). The Baltimore-based startup has designed a benchtop analyzer and disposable cartridge called the Jiddu that can detect bacterial infection in urine in one hour.
