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 drug company has stopped testing and will soon submit its data to the US 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., a first-line drug currently used to treat urinary tract infections.
The company said it would follow a recommendation from its independent data monitoring board 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 its data to the FDA for approval next year. That’s about a year ahead of the study’s scheduled completion date on the clinicaltrials.gov website.
“Stopping studies in such circumstances is a fairly rare event in the industry. So that’s something I’m absolutely thrilled about, both from a public health perspective and from a business perspective,” said GSK’s Chief Scientific Officer. Tony Wood, on a call with reporters, Thursday.
Gepotidacin works by blocking the enzymes bacteria need to unpack their DNA – their 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 necessary because developing new drugs is expensive and antibiotics tend not to generate large profits.
New antibiotics are desperately needed because over time many types of bacteria have become resistant to the agents used to treat them. A 2021 report from the World Health Organization warned that there were not enough new antibiotics in development to overcome the looming threat of antibiotic resistance. Antibiotic-resistant infections kill more than a million people worldwide each year.
“It’s definitely a big deal,” said Dr. Cindy Liu, chief medical officer of George Washington University’s Center for Action on Antibiotic Resistance.
“The antibiotic pipeline is what we would call quite permeable, because, you know, you end up with discontinued antibiotics,” Liu said, which means many drugs don’t move from phase one to phase two of human trials. Another cycle will be dropped between the second and third phase, usually because companies lack the funds to develop them. “And so that’s something that we’ve been dealing with, at the same time as there are an increasing number of infections that are increasingly difficult to treat with the drugs that we have.”
Liu said obtaining marketing approval for gepotidacin was only the first hurdle. She said she’s seen drugs gain approval, only to be dropped by their manufacturers when they don’t generate a profit.
Antibiotics do not generate large profits for pharmaceutical companies because patients only take them for a short time. They are not maintenance medications like cholesterol or depression medications. Eventually, if they are used enough, the bacteria they were developed for will develop resistance and the drugs will stop working. They therefore have a limited lifespan.
“I think it will be really interesting and important for the field to see both how pharmaceutical companies market this product and how it does it,” Liu said.
Urinary tract infections can affect men and women of any age, but are more common in women and girls, who have shorter urethras closer to the rectum, making it easier for urinary tract infections to occur. bacteria.
Urinary tract infections are 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 are becoming increasingly resistant to the drugs used to treat it.
Symptoms of UTIs include frequent painful or burning urination, bloody urine, low stomach cramps, and the need to urinate even after going outside.
In clinical trials of 3,000 women, GSK said gepotidacin achieved its goals of resolving symptoms of a UTI and eliminating the bacteria that caused it. The study compared gepotidacin to nitrofurantoin, which is currently recommended as first-line treatment.
Gepotidacin is taken as a pill. GSK is also testing it to treat gonorrhea, a sexually transmitted 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.
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