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GSK to submit drug application for new antibiotic to US FDA

Gepotidacin could be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years


GSK’s gepotidacin has shown promising results as a treatment for uncomplicated urinary tract infections (uUTI), with two the phase 3 trials in female adults and adolescents set to stop enrolment early for efficacy following a recommendation by the Independent Data Monitoring Committee (IDMC).

The company expects to submit regulatory filings to the US Food and Drug Administration in the first half of 2023 for gepotidacin which, if approved, could become the first drug in a new class of oral antibiotics for uUTIs in over 20 years, according to the company.

An estimated 150 million people are affected by UTIs each year, with approximately 80% of these cases caused by E coli. This often includes difficult-to-treat strains that are resistant to commonly used antibiotics.

Antibiotic-resistant E coli has been identified by both the US Centers for Disease Control and Prevention and World Health Organization as an ‘urgent and serious’ public health threat requiring development of new treatments.

Gepotidacin is a novel, investigational bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct mechanism of action and equally and independently binds to two different type 2 topoisomerase enzymes.

This provides activity against most strains of E coli and S saprophyticus, including isolates resistant to current antibiotics.

The EAGLE-2 and EAGLE-3 trials met the primary efficacy endpoint of combined clinical and microbiological resolution at 28 days following a five-day oral course of gepotidacin versus standard therapy nitrofurantoin in patients with a confirmed uUTI and a uropathogen sensitive to nitrofurantoin. The IDMC review did not identify any safety concerns, GSK outlined in a statement.

An additional study, EAGLE-1, is comparing the efficacy and safety of two oral doses of gepotidacin to a regimen based on an intramuscular dose of ceftriaxone and oral azithromycin in the treatment of uncomplicated urogenital gonorrhoea caused.

Chris Corsico, senior vice president, development, GSK, said: "uUTI are the most common outpatient infection with over half of all women developing a uUTI during their lifetime and more than a quarter of women suffering from recurrent uUTIs. There has been no new class of oral antibiotics for uUTI for over 20 years. With the number of uUTIs caused by resistance bacteria increasing, new antibiotic treatments are necessary.

"The IDMC’s recommendation to stop the EAGLE-2 and 3 trials early for efficacy provides GSK with the opportunity to engage regulatory authorities as we work together to bring a new class of antibiotics to patients with uUTIs.”

Article by
Emily Kimber

4th November 2022

From: Research, Regulatory



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