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news.GlaxoSmithKline (GSK) has launched a phase 3 clinical programme to evaluate its antibiotic candidate gepotidacin for the treatment of uncomplicated urinary tract infection (uUTI) and urogenital gonorrhoea (GC).
GSK begins dosing patients in phase 3 programme for gepotidacin. Photo: courtesy of GlaxoSmithKline plc.
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The UK-based pharma company said that it has started dosing of patients in the phase 3 programme, which will test gepotidacin in two studies – EAGLE-1 and EAGLE-2.
EAGLE-1 will evaluate the antibiotic candidate in comparison to ceftriaxone plus azithromycin for the treatment of urogenital gonorrhoea, which is considered to be one of the most common sexually transmitted infections. A total of nearly 600 patients will take part in the phase 3 trial in urogenital gonorrhoea.
EAGLE-2 will assess gepotidacin, in comparison to nitrofurantoin, in nearly 1200 patients with uncomplicated urinary tract infection. Also called acute cystitis, uncomplicated urinary tract infection is known to be a very common infection in women.
GSK expects to release the first results from the two phase 3 trials by the end of 2021.
According to the company, gepotidacin is the first in a new chemical class of antibiotics called triazaacenaphthylene bacterial topoisomerase inhibitors, which were developed in 2007 through a dual targeting mechanism of action and oral formulation.
The launch of the phase 3 programme for the antibiotic candidate comes after positive results from two phase 2 trials that evaluated it for the treatment of urogenital gonorrhoea, and acute bacterial skin and skin structure infections (ABSSSI).
The mid-stage study in urogenital gonorrhoea demonstrated that single, oral doses of the investigational antibiotic were at least 95% effective for eradicating bacteria of Neisseria gonorrhoea (NG).
The ABSSSI study revealed that two of the three doses of gepotidacin that were tested met pre-specified success criteria for clinical utility on the basis of efficacy and safety profile.
GSK chief scientific officer and R&D president Hal Barron said: “Given the increasing rate of antibiotic drug resistance, and gepotidacin’s unique mechanism of action, we believe this drug has the potential to transform the treatment landscape for patients with uncomplicated urinary tract infection and urogenital gonorrhoea who currently have limited therapeutic options.”