The first new type of antibiotic has been developed in more than 20 years of treatment for urinary tract infections (UTIs) appear to be so effective 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 Thursday that the new antibiotic, called gepotidacin, works at least as well as nitrofurantoin.And the Current front-line medication used to treat urinary tract infections.
The company said it would follow a recommendation from its independent data monitoring panel to stop the study early because the drug has already proven effective.
GSK said it will prepare its results 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 of the study on the Clintrials.gov website.
“Stopping studies in such circumstances is rare in the industry. It’s something I am absolutely delighted with, both from a public health and from a company perspective,” said GSK’s chief scientific officer. Tony Wood, on a call with reporters, Thursday.
gipotidacin It works by blocking the enzymes that bacteria need to decompress DNA – their operating instructions – so they can reproduce in the body.
Developed in partnership with the United States Government, as one of 19 projects currently funded by Advanced Biomedical Research and Development Authority, or BARDA, to combat antimicrobial resistance. Government investment was needed because developing new drugs is expensive, and antibiotics don’t generate much profit.
New antibiotics are badly needed because over time, many types of bacteria have become resistant to the agents used to treat them. A report from the World Health Organization in 2021 warned that there were not enough new antibiotics in development to overcome the looming threat of antibiotic resistance. Antibiotic-resistant infections kill more than 1 million people globally each year.
“It’s definitely a big deal,” said Dr. Cindy Liu, chief medical officer of the Center for Antibiotic Resistance at George Washington University.
“The antibiotic pipeline is what we might call a bit leaky, because, you know, you end up with antibiotics leaking,” Liu said, which means that many drugs don’t work from stage one to stage. The second of human experiences. Another round will end between phases two and three, usually because companies have run out of money to develop it. “And that’s something we’ve been dealing with, at the same time as there are increasing numbers of infections that are difficult to treat with the medications we have.”
Liu said obtaining marketing approval for gepotidacin was just the first hurdle. She said she’s watched the drugs win approval, only to have their manufacturers abandon them when they don’t turn a profit.
Antibiotics don’t make much money for drug companies because patients only take them for a short time. They are not maintenance medications like cholesterol or depression medications. Eventually, if used enough, the bacteria that were developed to kill it will develop resistance to it, and the drugs will stop working. So they have a limited life.
“I think it’s going to be really interesting and important for the industry to see how and how pharmaceutical companies kind of market this product,” Liu said.
Urinary tract infections can occur in both men and women of any age, but are more common in women and girls, who have a shorter urethra near the rectum, making it easier for bacteria to infect the urinary tract.
Urinary tract infection is one of the most common types of infection. Studies show that it affects 1 in 8 women each year and 1 in 5 women over the age of 65. Somewhere between 30% to 44% of UTIs are recurrent, which means they come back after treatment. Most are caused by Escherichia coli bacteria, which are becoming more resistant to the drugs used to treat them.
Symptoms of a urinary tract infection include frequent painful or burning urination, bloody urine, low stomach cramps, and the need to urinate even after just going.
In clinical trials of 3,000 women, GSK said gepotidacin achieved its goals of resolving UTI symptoms as well as removing the bacteria that cause it. The study compared gepotidacin with nitrofurantoin, which is currently recommended as a first-line treatment.
Gepotidacin is taken as a pill. GSK is also testing it to treat sexually transmitted infections (STIs) gonorrhea. On Thursday, GSK said the study testing gepotidacin for gonorrhea was ongoing and had not yet progressed to the same stage as the UTI trial.
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