LONDON (dpa-AFX) - GSK plc. (GSK, GSK.L) announced positive results from the
pivotal EAGLE-1 phase III trial for gepotidacin, a potential first-in-class oral
antibiotic with a novel mechanism of action for uncomplicated urogenital
gonorrhoea in adolescents and adults.

The results are based on a primary endpoint of microbiological response (success
or failure of eliminating the bacterial cause of gonorrhoea) at the Test-of-Cure
(ToC) visit 3-7 days after treatment.

The trial showed that gepotidacin (oral, two doses of 3,000mg) was non-inferior
with 92.6% success rates when compared to 91.2% success rates for intramuscular
(IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg) combined therapy, a
leading combination treatment regimen for gonorrhoea.

The company noted that the safety and tolerability profile of gepotidacin in the
EAGLE-1 trial was consistent with results seen in phase I and II trials. The
most commonly reported adverse events in gepotidacin subjects were
gastrointestinal. All adverse events were mild or moderate except for one
severe, unrelated event in each treatment arm and one unrelated serious event in
the gepotidacin arm.

Gonorrhoea is a sexually transmitted infection caused by bacteria called
Neisseria gonorrhoeae, which has been recognised by the World Health
Organisation as a priority pathogen. It affects both men and women and if
inadequately treated, it can lead to infertility and other sexual and
reproductive health complications. It also increases the risk of HIV infection.

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