Gonorrhea is one of the most widespread sexually transmitted infections, with as many as 82 million new infections occurring worldwide each year. While not all cases are symptomatic, if left untreated, gonorrhea can lead to serious health problems in both men and women. As a bacterial infection, gonorrhea is generally treated with antibiotics, but as antibiotic resistance becomes increasingly common around the world, the bacterium has evolved to resist many antibiotic classes. Only one antibiotic, ceftriaxone, is currently recommended as a treatment for the Neisseria gonorrhoeae bacterium. However, an antibiotic from the non-profit Global Antibiotic Research & Development Partnership (GARDP) and Innoviva Specialty Therapeutics could change the game. Read on to find out more about zoliflodacin, a new drug that, if approved, could become the first new antibiotic for gonorrhea in decades.
New Drug Targets Treatment-Resistant Gonorrhea
Zoliflodacin is currently undergoing clinical trials funded by GARDP and an Innoviva subsidiary. The primary stakeholders recently shared Phase 3 data assessing oral zoliflodacin in 930 patients across five countries. At the beginning of the trial, each of the patients was diagnosed with uncomplicated gonorrhea. They were treated at 16 trial sites in regions with a high prevalence of gonorrhea, including Belgium, the Netherlands, South Africa, Thailand, and the United States. The trial compared a single oral 3g dose of zoliflodacin to a globally recognized standard of care regimen.
Ultimately, zoliflodacin met the statistical test for non-inferiority when compared to the current standard of care for the infection, which involves intramuscular (IM) injection of ceftriaxone and oral azithromycin. In addition to generally matching the current standard of care, the drug was well-tolerated among participants. Patients saw no serious adverse events, and no fatalities were observed.
New Gonorrhea Drug Inhibits Key Bacterial Enzyme
The drug zoliflodacin is designed to inhibit type II topoisomerase, a bacterial enzyme that plays a key role in bacterial function and reproduction. It’s an effective approach. Previous in-vitro studies have shown that zoliflodacin shows promise against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin. “Positive results of this landmark Phase 3 trial confirm that zoliflodacin has the potential to tackle the most difficult-to-treat gonorrhea infections,” the stakeholders wrote in a recent press release.
Next Steps to Commercialize Effective Gonorrhea Treatment
GARDP, the sponsoring nonprofit organization, will have the right to register and commercialize the product in more than 75 percent of the world, the organization shared in a press release. Additionally, Entasis Therapeutics will hold commercial rights in certain North America, Europe, Asia-Pacific, and Latin America markets. While other investigational gonorrhea treatments are currently in development — GSK’s phase I/II vaccine candidate, for example — this treatment could provide rapid relief for parts of the world hit hardest by this infection.
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“The outcome of this study is a potential game changer for sexual health,” Edward Hook III, M.D., protocol chair for the study and Emeritus Professor of Medicine at the University of Alabama at Birmingham, said in the press release. “In addition to the potential benefits for patients with infections with resistant strains of Neisseria gonorrhoeae, the potential lack of cross-resistance with other antibiotics and the oral route of administration will simplify gonorrhea therapy for clinicians worldwide.”
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