Dubai, United Arab Emirates (CNN) – A new antibiotic, developed for the first time more than 20 years after the last license to treat urinary tract infections, has shown great effectiveness, which has encouraged the pharmaceutical company that developed it to stop testing it, and will provide its data Soon to the US Food and Drug Administration for approval.
Pharmaceutical company GSK said Thursday that the new antibiotic, called Gepotidacin, is at least as effective as nitrofurantoin, which is currently used to treat urinary tract infections.
The company announced that it would follow a recommendation from its independent data monitoring committee to stop the study early, as the drug has already proven effective.
The company said it will prepare its results for publication in a medical journal, and will submit its data to the Food and Drug Administration for approval next year.
“Stopping studies in such circumstances is rare in the industry,” said Tony Wood, GSK’s chief scientific officer, on a call with reporters, Thursday. “So it’s something that I am absolutely delighted with, both from a public health perspective and from a company perspective.”
Gepotidacin works by blocking the enzymes that bacteria need to break down their DNA, their operating instructions, so they can reproduce in the body.
The drug was developed in partnership with the US government, as one of 19 projects currently funded by the Biomedical Advanced Research and Development Authority, to combat antimicrobial resistance.
Government investment was needed because developing new drugs is very expensive, and antibiotics are not very profitable.
There is an urgent need for new antibiotics, as over time, many types of bacteria have become resistant to the agents used to treat them.
A 2021 report by the World Health Organization warns that there are not enough new antibiotics in development to overcome the looming threat of antibiotic resistance.
Antibiotic-resistant infections kill more than 1 million people worldwide each year.
Getting marketing approval for Gepotidacin was just the first hurdle, said Dr. Cindy Liu, chief medical officer of the Center for Antibiotic Resistance at George Washington University.
She noted that she’s seen drugs get approval, and their manufacturers abandon them when they don’t make a profit.
Antibiotics are not very profitable for drug companies because patients only use them for a short time, as they are not like cholesterol or depression drugs.
If antibiotics are used frequently enough, the bacteria that fight them will develop resistance to them, which will stop the drug’s effectiveness, so it has a limited lifespan.
Urinary tract infections can affect both men and women of any age, but they are more common in women and girls, who have a shorter urethra, making it easier for bacteria to infect the urinary tract.
Urinary tract infection is the most common type of infection, and studies show that it affects 1 in 8 women annually, and 1 in 5 women over the age of 65 years.
Even after treatment, urinary tract infections return between 30% and 44%, and most of them are caused by Escherichia coli bacteria, which have become more resistant to the drugs used to treat them.
Symptoms of a urinary tract infection include frequent urination, burning or pain when urinating, red-colored urine, low stomach cramps, and a constant need to urinate.
During clinical trials with 3,000 participating women, GSK demonstrated that Gepotidacin achieved its goals of resolving UTI symptoms and removing the bacteria that cause UTI.
The study compared Gepotidacin with nitrofurantoin, which is currently recommended as a first-line treatment.
Gepotidacin is taken in tablet form, and GSK is also testing it to treat sexually transmitted gonorrhea.