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The first new type of antibiotic was further developed For 20 years, it appears to be so effective at treating urinary tract infections (UTIs) that a pharmaceutical company has stopped trials and will soon submit its data to the US Food and Drug Administration for approval.
Drug company GSK said Thursday that a new antibiotic called gepotidacin works at least as well as nitrofurantoin., The current front-line drug used to treat UTIs.
The company said it would follow an independent data monitoring committee’s recommendation to stop the study early because the drug had already been shown to be effective.
GSK said it would prepare its results for publication in a medical journal and report to the FDA for approval next year. That’s nearly a year ahead of the expected completion date on the study’s website clinicaltrials.gov.
“Discontinuation of research in such circumstances is extremely rare in the industry. This is something I’m absolutely delighted about, both from a public health and company perspective,” said GSK’s Chief Scientific Officer Tony Wood at a press conference on Thursday.
Gepotidasin It works by blocking the enzymes that bacteria need to open their DNA – their operating instructions – to reproduce in the body.
It was also developed in collaboration with the US government It is one of 19 projects funded by Biomedical Advanced Research and Development Organization or BARDA to combat antimicrobial resistance. Government investment was needed because new drugs are expensive to develop and antibiotics are not very profitable.
New antibiotics are desperately needed because, over time, many types of bacteria become resistant to the agents used to treat them. in 2021 report There are not enough new antibiotics in development to tackle the looming threat of antibiotic resistance, the World Health Organization has warned. Antibiotic-resistant infections kill more than a million people worldwide every year.
“It’s definitely a big deal,” said Dr. Cindy Liu, MD, 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 being thrown out,” Liu said, noting that many drugs don’t make it past phase one to phase two of human trials. Another round will be left unfinished between the second and third stages, usually because companies run out of funds to develop them. “So it’s something we’re dealing with at the same time as we’re dealing with an increasing number of infections that are harder and harder to treat with the drugs we have.”
Getting marketing approval for gepotidacin is just the first hurdle, Liu said. He said he’s seen drugs win approval, only to be abandoned by their manufacturers when they don’t turn a profit.
Antibiotics are not very profitable for pharmaceutical companies because patients only take them for a short time. They do not contain medications such as cholesterol or depression medications. Eventually, if enough are used, the bacteria they are designed to kill will develop a resistance to them and the drugs will stop working. Hence, they have a limited lifespan.
“I think it’s going to be really interesting and important for the field to see both how drug companies bring this product to market and how it goes,” Liu said.
Urinary tract infections can occur in both men and women at any age, but more common in women and girlsthose with shorter urethras 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 and 1 in 5 women over the age of 65 each year. Between 30% and 44% of UTIs are recurrent, meaning they come back after treatment. Most are caused by E.coli bacteria and are more resistant to the drugs used to treat them.
Symptoms of a UTI include frequent urination with pain or burning, bloody urine, lower stomach cramps, and the need to urinate even after passing urine.
In clinical trials involving 3,000 women, GSK said gepotidacin achieved its goals of both relieving UTI symptoms and clearing the bacteria that cause it. The study compared gepotida with nitrofurantoin, which is currently recommended as first-line therapy.
Gepotidacin is taken in pill form. GSK is also testing it for the treatment of the sexually transmitted infection gonorrhea. On Thursday, GSK said its gepotidacin trial for gonorrhea was ongoing and had not yet reached the same stage as the UTI trial.
