The first new type of antibiotic developed later 20 years seems so effective for treating urinary tract infections (UTIs) that the drug company has stopped testing and will soon submit its data to the U.S. Food and Drug Administration for approval.
Pharmaceutical company GSK said on Thursday that the new antibiotic, called gepotidacin, works at least as well as nitrofurantoin., and current prodrug used to treat UTIs.
The company said it will follow the independent data monitoring committee’s recommendation to stop the study early, as the drug has already proven to be effective.
GSK said it will prepare its findings for publication in a medical journal and submit its data to the FDA for approval next year. This is about a year before the expected completion date on the study’s website. clinicaltrials.gov.
“It’s pretty rare in the industry to stop work in situations like these. So it’s something I’m absolutely happy with, both from a public health standpoint and the company’s,” said GSK Chief Scientific Officer. Tony Wood is meeting with reporters on Thursday.
gepotidacin It works by blocking the enzymes – the operating instructions – that bacteria need to open their DNA in order to reproduce in the body.
Developed in partnership with the US government because one of 19 projects currently funded by Biomedical Advanced Research and Development Agency, or BARDA, to combat antimicrobial resistance. Government investment was needed because developing new drugs was expensive and antibiotics did not yield big returns.
New antibiotics are sorely needed because over time many types of bacteria have become resistant to the agents used to treat them. and 2021 statement The World Health Organization warned that there are not enough new antibiotics to tackle the emerging threat of antibiotic resistance. Kills antibiotic-resistant infections more than a million people globally every year.
“It’s definitely a big deal,” said Dr. Cindy Liu is chief medical officer at the Center for Antibiotic Resistance Action at George Washington University.
“The antibiotic pipeline is something we’d call pretty leaky, because you know, you end up with antibiotics being discontinued,” Liu said, meaning that most of the drugs don’t make it through phase one to two of human trials. Between the second and third stage, another round will fall, often as companies run out of funds to develop them. “And that’s something we’re dealing with, also while we have a growing number of infections that are harder and harder to treat with the drugs we have.”
Getting marketing approval for gepotidasin is only the first hurdle, Liu said. He said the drugs were approved but abandoned by their manufacturers when they failed to make a profit.
Antibiotics aren’t big wins for pharmaceutical companies because patients only take them for a short time. They are not maintenance drugs like cholesterol or depression drugs. Eventually, if they are used enough, the bacteria they were developed to kill will develop resistance to them and the drugs will stop working. Therefore, they have a limited lifespan.
“I think it would be really interesting and important for the field to see how pharmaceutical companies market this product and how they do it,” Liu said. Said.
Urinary tract infections can happen to men and women of all ages, but these more common in women and girlsHaving shorter urethra that is closer to the rectum makes it easier for bacteria to infect the urinary tract.
UTIs are one of the most common infections. Studies show it affects 1 in 8 women each year and 1 in 5 women over the age of 65. Somewhere between 30% and 44% of UTIs recur, meaning they come back after treatment. Most are caused by E. coli bacteria, which have become more resistant to the drugs used to treat them.
UTI symptoms include frequent urination that is painful or burning, bloody urine, low stomach cramps, and the need to urinate even after you’ve gone.
In clinical trials of 3,000 women, GSK said gepotidasin achieved its goals of both resolving UTI symptoms and clearing the bacteria that cause it. The study compared nitrofurantoin, currently recommended as first-line therapy, with gepotidasine.
Gepotidacin is taken as a pill. GSK is also testing it to treat the sexually transmitted infection gonorrhea. On Thursday, GSK said the gepotidacin test study for gonorrhea is ongoing and has not yet progressed to the same stage as the UTI trial.