Antibiotic Pill Gepotidacin

A new antibiotic is effective against infections of the urinary tract, a drug company claims

The first antibiotic to be developed to treat UTIs in over 20 years appears to have been so successful that the pharmaceutical company has stopped testing and will submit its data to US Food and Drug Administration soon for approval.

GSK, a drug company, said that Thursday’s new antibiotic, gepotidacin was at least as effective as nitrofurantoin (a current first-line medication to treat UTIs).

According to the company, it will follow the recommendation of its independent data monitoring committee to end the study before the results are known.

GSK stated that it would publish its findings in a medical journal and submit the data to FDA for approval next year. This is about one year before the expected completion date of the study on clinicaltrials.gov.

“Stopping studies under such circumstances is an extremely rare occurrence in this industry. Tony Wood, Chief Scientific Officer at GSK, said that he is thrilled about the opportunity, from both a company and public health perspective. He spoke to reporters on Thursday.

Gepotidacin blocks enzymes that bacteria require to unzip DNA (their operating instructions) so they can multiply in their bodies.

This project was created in partnership with the US government and is one of 19 currently funded by the Biomedical Advanced Research and Development Authority (or BARDA) to combat antimicrobial resistance. Because new drugs can be expensive and do not turn large profits, government investment is necessary.

Because many bacteria strains have developed resistance to antibiotics over the years, new antibiotics are urgently needed. The World Health Organization issued a 2021 report warning that there aren’t enough new antibiotics being developed to combat the growing threat of antibiotic resistance. Globally, antibiotic-resistant infections cause more than 1 million deaths each year.

“It’s certainly a big deal,” Dr. Cindy Liu said, chief medical officer of the Antibiotic Resistance Action Center at George Washington University.

Liu stated that the antibiotic pipeline was “very leaky” and many drugs fail to make it through human trials. Between the second and third phases, another round will be lost due to companies running out of funds. “And so, this is something we have been dealing with, while there are increasing numbers of infections that are more difficult to treat with the medications that we do have.

Liu stated that getting marketing approval for gepotidacin wasn’t the only hurdle. She stated that she has seen drug approvals be denied and then abandoned by the manufacturers because they aren’t making a profit.

Because antibiotics are only used for a brief time, they don’t make pharmaceutical companies a lot of money. They aren’t maintenance drugs like drugs for depression or cholesterol. If they are not used enough, the bacteria they were designed to kill will become resistant to them and the drugs will cease to work. They have a short life span.

Liu stated that he believes it would be very interesting and crucial for the field to observe how drug companies market the product and how it performs.

Both men and women can get urinary tract infections. However, they are more common in girls and women who have shorter urethras and are closer to their rectum. This makes it easier for bacteria and viruses to infect the urinary system.

UTIs are the most common type of infection. They affect 1 in 8 women and 1 in 5 over 65 years old, according to studies. UTIs that are persistent can occur from 30% to 44%. This means they return after treatment. Many are caused by E.coli bacteria which are becoming more resistant to drugs.

UTIs can cause frequent, painful, or even burnt urination, bloody urine, stomach cramps, and the need for a second urination.

GSK found that gepotidacin achieved its goals in clinical trials with 3,000 women. It was able to both relieve the symptoms of a UTI and clear the bacteria that caused it. GSK compared gepotidacin with nitrofurantoin in a study. This is the current recommended first-line treatment.

Gepotidacin can be taken as a tablet. GSK is also testing the drug to treat sexually transmitted infections and gonorrhea. GSK announced Thursday that the study to test gepotidacin in gonorrhea is ongoing, but had not reached the same stage of the UTI trial.

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