Researchers Reveal Positive Data on New Antibiotic for Super Gonorrhea

On November 1, 2023, the Global Antibiotic Research and Development Partners (GARDP) and Innoviva Specialty Therapeutics, a subset of Innoviva Inc, issued a co-authored press release announcing that a new antibiotic was the first antibiotic in the spiropyrimidinetriones class of antibacterial agents.

According to the University of Minnesota Center for Infectious Disease Research and Policy, zoliflodacin is the first antibiotic to utilize a different mechanism for treating Neisseria gonorrhoeae. The GARDP and Innoviva press release clarified that the drug inhibits type II topoisomerase, which, in turn, compromises bacterial function and reproduction.

Before the inception of the most recent phase 3 clinical trial, other in vitro trials had demonstrated zoliflodacin’s ability to treat multidrug-resistant N. gonorrhoeae, otherwise called super gonorrhea. The organization revealed that previous attempts have provided evidence that the drug could treat strains resistant to ceftriaxone and azithromycin.

With evidence from existing research, the investigators launched a global phase 3 clinical trial that recruited 930 patients with uncomplicated gonorrhea across 16 trial sites in Belgium, the Netherlands, South Africa, Thailand, and the United States.

Patients were randomized to receive a 3 g dose of zoliflodacin or the standard treatment regimen, which includes a 500 mg intramuscular injection of ceftriaxone and 1 g oral azithromycin.

Comparing data from both groups, the researchers concluded that zoliflodacin was as effective as the standard treatment protocol for  More specifically, the statistical test for noninferiority yielded outcomes within the non-inferiority margins specified by the US Food and Drug Administration (FDA).

“The success of this study could have a profound effect on how physicians approach gonorrhea infections, as an oral alternative to an injection could improve patient access and compliance, as well as help reduce the increasing spread of antibiotic-resistant strains of the disease,” said Pavel Raifeld, Chief Executive Officer, Innoviva, Inc, in the press release. “Such a positive outcome represents an important milestone for Innoviva Specialty Therapeutics and reinforces our position as a premier infectious disease and critical care company.”