Zoliflodacin was effective in treating gonococcal urogenital and rectal infections, but was less effective than ceftriaxone for the treatment of pharyngeal gonorrhea, according to results published in the New England Journal of Medicine.
The incidence of gonorrhea has increased by 67% in the United States from 2013 to 2017, and at the same time, antimicrobial resistance of Neisseria gonorrhoeae also increased. New treatments are needed, and zoliflodacin (also known as AZD0914 or ETX0914), an investigational spiropyrimidinetrione antimicrobial agent, has received “fast track” designations from the US Food and Drug Administration for development as an oral treatment for gonococcal infections. In this study, researchers randomly assigned 179 individuals with possible and/or confirmed exposure to gonorrhea to receive either a single oral dose of zoliflodacin (2 or 3 g) or a single 500-mg intramuscular dose of ceftriaxone, in a ratio of approximately 70:70:40.
Of the 141 evaluable participants, a microbiologic cure at urogenital sites was observed 55/57 (96.5%) of those in the 2 g zoliflodacin group, 54/56 (96.4%) in the 3 g zoliflodacin group, and 28/28 (100%) who received ceftriaxone. All rectal infections were cured in participants who received 2 or 3 g zoliflodacin and ceftriaxone. Pharyngeal infections were cured in 4/8 (50%), 9/11 (82%), and 4/4 participants (100%) who received 2 g zoliflodacin, 3 g zoliflodacin, and ceftriaxone, respectively.
“Reports of multidrug-resistant N gonorrhoeae and the possibility of untreatable gonorrhea underscore the need for the development of new antimicrobial agents,” concluded the researchers. “This phase 2 trial creates equipoise for larger, more definitive studies of zoliflodacin.”