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.
The drug company GSK said on Thursday that the new antibiotic, called gepotidacin, works at least as well as nitrofurantoin, a current first-line drug used to treat UTIs.
The company said it would follow a recommendation by the independent data monitoring committee to stop the study early because the drug had already been shown to be effective.
GSK said it would prepare its findings for publication in a medical journal and submit the data to the FDA for approval next year. That’s about a year before the study’s expected completion date on the clinicaltrials.gov website.
“Stopping studies in such circumstances is a fairly rare occurrence in the industry. So it’s something I’m very happy about, both from a public health and from a company perspective, says the GSK Chief Scientific Officer Tony Wood, on a call with reporters, Thursday.
Gepotidacin works by blocking enzymes that bacteria need to unpack their DNA – their instruction manual – so they can reproduce in the body.
It was developed in collaboration with the US government, as one of 19 projects currently funded by Biomedical Advanced Research and Development Authority, or BARDA, to combat antimicrobial resistance. Government investment was necessary because new drugs are expensive to develop, and antibiotics tend not to make big profits.
New antibiotics are desperately needed because over time many types of bacteria have become resistant to the drugs used to treat them. A 2021 World Health Organization report warned that 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, medical director of 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 falling out,” Liu said, meaning many of the drugs don’t make it from the first to the second phase of human trials. Another round will fall out between the second and third phases, typically because companies run out of funds to develop them. “And so this is something we’ve been dealing with, at the same time there are increasing numbers of infections that are harder and harder to treat with the drugs we have.”
Liu said getting marketing approval for gepotidacin was only the first hurdle. She said she has seen drugs win approval, only to be abandoned by manufacturers when they don’t make money.
Antibiotics do not generate large profits for pharmaceutical companies because patients only take them for a short time. They are not maintenance drugs like drugs for cholesterol or depression. Eventually, if they are used enough, the bacteria they were designed to kill will develop resistance to them and the drugs will stop working. So they have a limited lifespan.
“I think it will be very interesting and important for the field to see both how drug companies market this product and how it does it,” Liu said.
Urinary tract infections can happen to both men and women of all ages, 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.
UTI is one of the most common infections. Studies show that they affect 1 in 8 women each year and 1 in 5 women over the age of 65. Somewhere between 30% and 44% of UTIs are recurrent, meaning they come back after treatment. Most are caused by E. coli bacteria, which become more resistant to the drugs used to treat them.
Symptoms of urinary tract infections include frequent urination that is painful or burning, bloody urine, low abdominal cramps, and the need to urinate even after passing.
In clinical trials of 3,000 women, GSK said gepotidacin met its goals of both resolving the symptoms of a UTI and clearing the bacteria that cause it. The study compared gepotidacin with nitrofurantoin, which is currently recommended as first-line treatment.
Gepotidacin is taken as a pill. GSK is also testing it to treat the sexually transmitted infection gonorrhea. On Thursday, GSK said the study testing gepotidacin for gonorrhea was ongoing and had not yet reached the same stage as the UTI study.