Successful Phase II data for gepotidacin for the treatment of uncomplicated urogenital gonorrhea.- GSK.

Phase II data was recently published in Clinical Infectious Diseases that showed that oral gepotidacin was more than 95% effective against uncomplicated urogenital gonorrhea. These results suggest that gepotidacin (GlaxoSmithKline) � a novel triazaacenaphthylene bacterial type II topoisomerase inhibitor � could serve as an alternative treatment option for Neisseria gonorrhoeae (NG), according to Stephanie N. Taylor, MD, infectious disease specialist at Louisiana State University Health Sciences Center in New Orleans, and colleagues.

For the phase II trial, Taylor and colleagues evaluated the safety, tolerability and efficacy of gepotidacin in 69 patients with uncomplicated urogenital NG. The participants were enrolled at one of 12 sites in the United States (n = 11) and the United Kingdom from April 2015 to August 2016. They were randomly assigned in a 1:1 ratio to receive 1,500 mg (n = 30) or 3,000 mg (n = 39) of oral gepotidacin. Only two women were included in the microbiologically evaluable analysis, including one in the 1,500 mg (low-dose) group and one in the 3,000 mg (high-dose) group. Microbiological eradication was achieved in 97% of participants in the low-dose group and 85% of participants in the high-dose group at the test-of-cure visit, which was 4 to 8 days after treatment. The combined efficacy of both doses was 96%. Fifty-two percent of participants in the low-dose group and 64% in the high-dose group reported adverse events, mostly diarrhea (27%), flatulence (23%), abdominal pain (15%) and nausea (13%). None of these events led to treatment discontinuations, and no deaths or serious adverse events were reported. However, one participant with no underlying cardiovascular history developed mild tachycardia, which the researchers said was possibly related to the study drug.

See-"Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: A Phase II, Randomized, Dose-Ranging, Single-Oral Dose Evaluation"- Stephanie N Taylor, David H Morris, Ann K Avery, Kimberly AWorkowski, Byron E Batteiger ... Clinical Infectious Diseases, ciy145, https://doi.org/10.1093/cid/ciy145.