The first new type of antibiotic developed in more than 20 years to treat urinary tract infections (UTIs) appears to be so effective that the pharmaceutical company stopped testing and will soon submit its data to the US Food and Drug Administration for approval.
Drug company GSK said Thursday the new antibiotic, called gepotidacin, works at least as well as nitrofurantoin, a current front-line medication used to treat UTIs.
The company said it would follow a recommendation from its independent data monitoring committee to stop the study early because the drug had already proven to be effective.
GSK said it would prepare its findings for publication in a medical journal and submit its data to the FDA for approval next year. That’s about a year ahead of the study’s anticipated completion date on the website clinicaltrials.gov.
“Stopping studies in such circumstances is a pretty rare occurrence in the industry. So it’s something I’m absolutely delighted about, both from public health and from a company perspective,” said GSK Chief Scientific Officer Tony Wood, on a call with reporters, Thursday.
Gepotidacin works by blocking enzymes that bacteria need to unzip their DNA – their operating instructions – so they can multiply in the body.
It was developed in partnership with the US government, as one of 19 projects currently funded by the Biomedical Advanced Research and Development Authority, or BARDA, to combat antimicrobial resistance. Government investment was needed because new drugs are expensive to develop, and antibiotics tend not to turn large profits.
New antibiotics are desperately needed because over time, many kinds of bacteria have become resistant to the agents used to treat them. A 2021 report from the World Health Organization warned there are not enough new antibiotics in development to overcome the looming threat of antibiotic resistance. Antibiotic resistant infections kill more than a million people globally each year.
“It’s definitely a big deal,” said Dr. Cindy Liu, chief medical officer at the Antibiotic Resistance Action Center at George Washington University.
“The antibiotic pipeline is what we would call pretty leaky, because, you know, you end up with antibiotics dropping out,” Liu said, meaning many of the drugs don’t make it from the first to second phase of human trials. Another round will drop out between the second and third phase, typically because companies run out of funds to develop them. ”And so this is something that we’ve been dealing with, at the same time when there are increasing numbers of infections that are harder and harder to deal with the drugs that we do have.”
Liu said getting marketing approval for gepotidacin was just the first hurdle. She said she’s seen drugs win approval, only to be abandoned by their manufacturers when they don’t turn a profit.
Antibiotics don’t generate large profits for pharmaceutical companies because patients only take them for a short time. They aren’t maintenance medications like drugs for cholesterol or depression. Eventually, if they are used enough, the bacteria they were developed to kill will develop resistance to them, and the drugs will stop working. So they have a limited lifespan.
“I think it will be really interesting and important to the field to see both how the drug companies sort of market this product and sort of how it does,” Liu said.
Urinary tract infections can happen to both men and women of any age, but are more common in women and girls, who have shorter urethras that are closer to the rectum, making it easier for bacteria to infect the urinary tract.
UTIs are one of the most common infections. Studies show they afflict 1 in 8 women each year and 1 in 5 women over age 65. Somewhere between 30% to 44% of UTIs are recurrent, meaning they come back after treatment. Most are caused by E. coli bacteria, which are becoming more resistant to the drugs used to treat them.
Symptoms of UTIs include frequent urination that is painful or burns, bloody urine, low stomach cramps and the need to urinate even after having just gone.
In clinical trials of 3,000 women, GSK said gepotidacin met its goals of both resolving the symptoms of a UTI as well as clearing the bacteria causing it. The study compared gepotidacin to nitrofurantoin, which is currently recommended as a first-line therapy.
Gepotidacin is taken as a pill. GSK is also testing it to treat the sexually transmitted gonorrhea infection. 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.