GSK starts a phase III clinical programme for a potential first-in-class antibiotic, gepotidacin.

GlaxoSmithKline plc> announced that patient dosing has begun in a phase III clinical programme investigating gepotidacin , the first in a new chemical class of antibiotics called triazaacenaphthylene bacterial topoisomerase inhibitors, in patients with uncomplicated urinary tract infection (uUTI, also known as acute cystitis) and urogenital gonorrhoea (GC)

. The phase III programme, comprising two studies, will test gepotidacin in two common infections caused by bacteria identified as antibiotic resistant threats by the Centers for Disease Control and Prevention, a division of the US Department of Health and Human Services. The first study (EAGLE-1) will compare gepotidacin to ceftriaxone plus azithromycin, a guideline recommended dual therapy approach, in approximately 600 patients with GC, one of the most common sexually transmitted infections. The second study (EAGLE-2) will compare gepotidacin to nitrofurantoin, a licensed first-line antibiotic, in approximately 1200 patients with uUTI, an infection that is very common in women. First results are expected by the end of 2021.

The progress into phase III development follows positive results from two phase II studies that evaluated gepotidacin for the treatment of GC, and acute bacterial skin and skin structure infections (ABSSSI). The GC study showed that single, oral doses of gepotidacin were at least 95% effective for bacterial eradication of Neisseria gonorrhoea (NG) in adult participants with uncomplicated urogenital gonorrhoea. The ABSSSI study showed that two of the three doses of gepotidacin tested met prespecified success criteria for clinical utility in terms of efficacy and safety profile.

The development of gepotidacin is the result of a successful public-private partnership between GSK, the US government�s Biomedical Advanced Research and Development Authority (BARDA) and Defense Threat Reduction Agency (DTRA). This collaboration was established in 2013 with the aim to support the development of several antibiotics to fight antibiotic resistance and bioterrorism.