The new antibiotic appears to be effective against urinary tract infections, the company said



CNN

More than the first new type of antibiotic was developed After 20 years, it appears to be so effective in treating urinary tract infections (UTIs) that the pharmaceutical company has stopped testing it 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 as well as nitrofurantoin., A first-line medication used to treat UTIs.

The company said it would follow the recommendation of its 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 its data to the FDA for approval next year. That’s one year before the study’s expected end date on clinicaltrials.gov.

“Stopping studies in such circumstances is quite rare in the industry. So it’s something I’m very happy about, both from a public health and a company perspective,” said GSK’s chief scientific officer. Tony Wood, in a call with reporters on Thursday.

Gepotidacin It blocks the enzymes that bacteria need to decompress DNA (their operating instructions) so they can multiply in the body.

It was developed in partnership with the US government and is one of 19 projects currently funded Biomedical Research and Advanced Development Authority or BARDA, to combat antimicrobial resistance. Government investment was needed because new drugs are expensive to develop and antibiotics are not profitable.

New antibiotics are urgently needed because, over time, many types of bacteria have become resistant to the agents used to treat them. A 2021 report by the World Health Organization warned that there are not enough new antibiotics in development to overcome the 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, medical director of the Antibiotic Resistance Action Center at George Washington University.

“The antibiotic pipeline is what we would call quite leaky because, you know, you get rid of the antibiotics,” Liu said, meaning that many drugs don’t make it from the first phase of human trials to the second. Another round will be left between the second and third phase, because companies usually run out of funds to develop them. “And so it’s something that we’ve been dealing with when there are more and more infections that are harder and harder to treat with the drugs that we have.”

Liu said getting marketing approval for gepotidacin was just the first hurdle. He said he’s seen drugs gain approval only to be abandoned when manufacturers aren’t making a profit.

Antibiotics do not generate much profit 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 designed to kill will develop resistance, and the drugs will stop working. So they have a limited life.

“I think it will be really interesting and important for the field to see how drug companies market this product and how they do it,” Liu said.

Urinary tract infections can occur in 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. Research shows that every year 1 in 8 women and 1 in 5 women over the age of 65. Between 30% and 44% of UTIs recur, meaning they come back after treatment. Most are caused by E. coli bacteria, which are more resistant to the drugs used to treat them.

Symptoms of UTIs include: frequent urination that is painful or burning, bloody urine, stomach cramps, and the need to urinate even if you just passed.

In clinical trials with 3,000 women, GSK said gepotidacin met its goals of resolving the symptoms of a UTI and clearing the bacteria that cause it. The study compared gepotidazine with nitrofurantoin, which is currently recommended as first-line therapy.

Gepotidacin is taken as a pill. GSK is also testing it to treat the sexually transmitted infection gonorrhea. On Thursday, GSK said a study testing gepotidazine for gonorrhea was ongoing and had not yet reached the same stage as the UTI trial.