GSK offers glimpse at positive Phase 3 antibiotic data for urogenital gonorrhea

Two months af­ter its uro­gen­i­tal gon­or­rhea an­tibi­ot­ic hit the pri­ma­ry end­point in a reg­is­tra­tional tri­al, GSK is pro­vid­ing a clos­er look at re­sults as it gears up for reg­u­la­to­ry fil­ings in 2025.

The Phase 3 EA­GLE-1 tri­al com­pared GSK’s an­tibi­ot­ic with stan­dard-of-care cef­tri­ax­one plus azithromycin in 600 peo­ple with un­com­pli­cat­ed uro­gen­i­tal gon­or­rhea. In the pri­ma­ry end­point of mi­cro­bi­o­log­i­cal re­sponse at the test-of-cure vis­it three to sev­en days af­ter treat­ment, gepoti­dacin achieved a 92.6% suc­cess rate ver­sus 91.2% for con­trol, per a Wednes­day re­lease. The p-val­ue of the non-in­fe­ri­or­i­ty end­point was not dis­closed.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.