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GSK, pushing back UTI filing by a year, shows antibiotic's gonorrhea potential in phase 3

2024-02-26

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临床3期临床结果上市批准合格传染病产品

Readouts from the EAGLE-2 and EAGLE-3 phase 3 trials last year showed gepotidacin held its own against nitrofurantoin as a UTI treatment.

GSK may have pushed back plans to secure approval for gepotidacin as tgepotidacinw urinary tract infectnitrofurantointment UTI20 years, but fresh phase 3 results have lined up the antibiotic for a separate filing to treat gonorrhea.

GSKthe late-stage EAGLE-1 trial of around 600 patientsgepotidacin-mg daily doses ofurinary tract infection (UTI)ys demonstrated noninferiority to the most common treatment for gonorrhea—an injection of the antibiotic ceftrgonorrhead oral dose of the antibiotic azithromycin—when assessed by microbiological response between three and seven days later. This hit the study’s primary endpoint.

The safety and tolerability profile of gepotidacin was consistent with phase 1 and 2 resugepotidacindrug, said GSK, which plans to share detailed results “at an upcoming scientgonorrheaing and with global health authoceftriaxone azithromycin

“With rising incidence rates and concergepotidacinowing resistance to existing treatments, gonorrhea poses a thGSKt to public health globally,” Chris Corsico, GSK’s senior vice president, development, said in the Feb. 26 release.

Gepotidacin had already turned heads by its ability to show “statistical superiority” as a gonorrhea for uncomplicated UTI compared to the commonly used UTI anGSKiotic nitrofurantoin in an in-depth readout of the EAGLE-3 phase 3 trial in April 2023, while the late-stage EAGLE-2 trial also showed that gepotidacin held its own against nitrofurantoin.

Gepotidacin, GSK stated plans to submit gepotidacin for regulatory approval for UTI by June 2023. But theuncomplicated UTI in its full-year earnings repoUTI(PDF) at thenitrofurantoiny 2024 that the deadline has been pushed all the way back to the second half of this year, with an FDA decision now expegepotidacin5.nitrofurantoin

GSK is currenGSK working with the FDA togepotidacinnclinical data for review aheUTIof the submission, a spokesperson told Fierce Biotech this morning. The company is also working in parallel with the FDA to prepare a gonorrhea application in the wake of an approval in UTI.FDA

GSKpite the delayed timeline, todaFDA gonorrhea data were further affirmation for GSK’s decision to continue to persevere in the antibiotics space even as most Big Pharma peers have long since checkedFDAt.gonorrhea UTI

Gepotidacin is the first in a new clasgonorrheaical antibiotics called triazaacenaphthylene bacterial topoisomerase inhibitors. While the company has been tinkering with the asset since 2007, the story really begins in 2013 with a public-private partnership between the Big Pharma and the U.S. government’s Biomedical Advanced Research and Development Authority to develop new weapons in the fight against antibiotic resistance and bioterrorism.

Gepotidacinelatively low return on investment has deterred plenty of larger drug developers from the space, GSK has continued to weave antibiotics into its business development plans, including paying $66 million upfront in September 2022 to license Spero Therapeutics' tebipenem HBr oral tablets, followed Biomedical Advanced Research and Development Authority FDA-approved antifungal called Brexafemme for the treatment of vulvovaginal candidiasis. GSK's antibiotic for tuberculosis is also set to read out further phase 2 data later this year.

Talking to Fierce Biotech a year ago, Melanie Paff, who heads up GSK's hepatitis B program, said antibioticsGSKe “a really hard space to play in because the science and the biology is so difficult.”Spero Therapeutics Scynexis Brexafemme vulvovaginal candidiasis GSK tuberculosis

“When you see the data coming out from gepo[tidacin], for instance—thathepatitis Bought,” she said at the time. “The chemists wouldn't give up, the biologists wouldn't give up, the clinical people wouldn't give up. And I'm really pleased to see that go forward and get the recognition that it deserves.”

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