Zoliflodacin, an investigational antibiotic, appears to be an effective treatment for uncomplicated urogenital and rectal gonococcal infections, according to a Phase 2 study published in The New England Journal of Medicine.

Unlike other antibiotics used to treat gonorrhea, zoliflodacin, a spiropyrimidinetrione antimicrobial agent, works by inhibiting DNA biosynthesis by arresting the cleaved covalent gyrase complex, thereby impeding bacterial growth. This novel treatment has been granted Fast Track designation by the Food and Drug Administration.

In the study, patients with gonorrhea (N=141) were randomized to receive either a single dose of zoliflodacin  2g or 3g orally or ceftriaxone 500mg IM. The proportion of patients with urogenital microbiologic cure was designated the primary measure of efficacy, while cure rates for pharyngeal and rectal infection were deemed secondary endpoints.

Related Articles

Results showed a 96% cure rate in patients who received zoliflodacin 2g (55 of 57 patients) and zoliflodacin 3g (54 of 56 patients) vs 100% in those who received ceftriaxone (28 of 28 patients). Rectal infections were cured in all treated patients (5 in the zoliflodacin 2g group, 7 in the zoliflodacin 3g group and 3 in the ceftriaxone group), while pharyngeal infections were cured in 50% of the zoliflodacin 2g group (4 of 8), 82% of the zoliflodacin 3g group (9 of 11) and 100% of the ceftriaxone group (4 of 4). Gastrointestinal-related side effects were the most common adverse events reported with zoliflodacin therapy.

“Since there is no vaccine to prevent gonorrhea, and the possibility of untreatable gonorrhea is looming larger, it is imperative that we develop new drugs to treat it. Our promising early results suggest that zoliflodacin could be one of them,” said Stephanie N. Taylor, MD, Professor of Medicine and Microbiology at LSU Health New Orleans School of Medicine.

For more information visit NEJM.org.