GSK reports positive results from gonorrhoea treatment trial
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announced encouraging headline outcomes from its trial of gepotidacin, an oral antibiotic aiming to address uncomplicated urogenital gonorrhoea in adolescents and adults, on Monday.
The FTSE 100 pharmaceuticals giant said the 'EAGLE-1' phase three trial met its primary efficacy endpoint by demonstrating non-inferiority of gepotidacin when compared to the combination therapy of intramuscular ceftriaxone plus oral azithromycin, which is the current main treatment regimen.
It said the evaluation was based on microbiological response recorded at the test-of-cure visit conducted three to seven days after treatment.
GSK said the safety and tolerability profile of gepotidacin remained consistent with findings from prior phase one and two trials.
Detailed outcomes from the trial are set to be unveiled at an upcoming scientific gathering and will be shared with global health regulatory bodies.
Additionally, GSK said it was exploring the potential of gepotidacin in treating uncomplicated urinary tract infections (uUTI).
It said positive results from phase three trials EAGLE-2 and EAGLE-3 were presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in April last year, and subsequently published in the Lancet.
Those results suggested that gepotidacin could become the first oral antibiotic in over two decades for treating uUTIs, if approved.
"With rising incidence rates and concern around growing resistance to existing treatments, gonorrhoea poses a threat to public health globally," said GSK's senior vice-president of development, Chris Corsico.
"These positive headline results demonstrate the potential for gepotidacin to provide a novel oral treatment option in the face of rising resistance and for patients who cannot take other treatments due to allergies or intolerance."
At 0814 GMT, shares in GSK were up 0.52% at 1,681.04p.
Reporting by Josh White for Sharecast.com.
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