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(Sharecast News) - GSK unveiled encouraging outcomes from a pivotal phase three trial on Wednesday, on the potential of gepotidacin as an oral treatment for uncomplicated urogenital gonorrhoea (GC), amid escalating resistance to current therapies.
The FTSE 100 pharmaceutical giant said the trial's primary endpoint, microbiological response at the test-of-cure (ToC) visit, showed a 92.6% success rate, rendering it non-inferior to the leading combination therapy comprising intramuscular (IM) ceftriaxone and oral azithromycin.
Notably, gepotidacin's safety profile mirrored previous phase one and two trials, with gastrointestinal adverse events being the most commonly reported, predominantly mild or moderate in nature.
Gonorrhoea, a prevalent global concern, sees around 82 million new cases annually worldwide.
In the United States alone, reported cases surged 118% from 2009 to 2021, as per the CDC, with nearly half displaying resistance to at least one antibiotic.
The infection, caused by neisseria gonorrhoeae bacteria, poses risks including infertility and heightened vulnerability to HIV.
Beyond its application in gonorrhoea, GSK said gepotidacin held promise for addressing uncomplicated urinary tract infections (uUTI).
Positive phase three data from the EAGLE-2 and EAGLE-3 trials, disclosed at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in April last year and published in the Lancet, underscored its potential significance as the first oral antibiotic class in uUTI in over two decades.
The company said the development of gepotidacin had received federal support, notably from the US Department of Health and Human Services and the Defense Threat Reduction Agency.
"These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide including drug resistant infections," said GSK's senior vice-president of development, Chris Corsico.
"The imperative for innovative treatments has never been clearer.
"We are committed to working with health regulators globally to introduce this potential new antibiotic, focusing on solutions that meet critical patient needs."
At 0808 BST, GSK shares were down 0.9% at 1,596p.
Reporting by Josh White for Sharecast.com.
