The antibiotic succeeded in late-stage human studies, setting up the drug to be a new treatment for urinary tract infections, the pharma GSK said.
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A new treatment for urinary tract infections got a step closer to reality on Thursday.
The pharma giant GSK said it has stopped two late-stage clinical studies early, because they've already shown its experimental pill works at treating UTIs.
The drug, called gepotidacin, could become the first new oral antibiotic for uncomplicated UTIs in more than two decades, according to the company. GSK plans to apply for approval in the first half of 2023, which could set up an approval decision in late 2023 or early 2024, going by typical drug review timelines.
In a statement, GSK's senior vice president of development Chris Corisco highlighted the need for new antibiotics as more UTIs are caused by resistance bacteria. For years, global public-health officials have warned about the growing threat from strains of bacteria that grow resistant to available treatments. GSK has been working with the US government to develop gepotidacin since 2013.
UTIs are incredibly common, with about 60% of women and 12% of men having at least one UTI in their life, according to the Urology Care Foundation. GSK's drug was tested in uncomplicated UTIs, which are restricted to the the bladder and urethra and are generally less serious than complicated UTIs. If left untreated, UTIs can cause serious damage to the body and even be life-threatening.
GSK's new drug started late-stage testing, called Phase 3 studies, just over three years ago. On Thursday, GSK said two studies enrolled over 3,000 patients with uncomplicated UTIs. The drug met the key effectiveness goal in both studies of ending the symptoms and signs of infection. A third trial testing the pill against a type of gonorrhea is ongoing.
The company described the results in a Thursday press release, adding it plans to publish the findings in a medical journal in 2023.
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The $66 billion drugmaking giant has had a rocky tenure throughout the pandemic. Most notably, the British pharma lost its position as the world's largest vaccine business by failing to develop a COVID-19 vaccine.
The company has undergone a serious shake-up since, spinning off its $36 billion consumer-health business this summer that oversees brands like Advil, Tums, and Sensodyne. The pared-down version of GSK, which CEO Emma Walmsley has called "New GSK," is solely focusing on drug and vaccine development.
GSK's leadership has also gone through some changes, including the departures of R&D head Hal Barron, vaccines chief Roger Connor, and Sally Mossman, who ran the Rockville, Maryland vaccine R&D site. The former Pfizer vaccine executive Phil Dormitzer joined last December "to restore GSK vaccines to leadership," as he told Insider in an August 2022 interview.
While GSK missed on COVID-19 vaccines, its antibiotic efforts could have a major impact on a slower-moving crisis in antimicrobial resistance. Most Big Pharmas have ignored the space, citing the lack of profit potential.
GSK, on the other hand, paid $66 million in September to license another antibiotic program being tested to treat complicated UTIs. That pill is expected to start late-stage testing in 2023.
