‘Potential game changer’: Gonorrhea antibiotic compares to standard of care in phase 3

An antibiotic from the non-profit Global Antibiotic Research & Development Partnership (GARDP) and Innoviva Specialty Therapeutics has met the current standard-of-care for gonorrhea, hitting the main goal of a pivotal phase 3 trial.

If approved, the drug could become the first new antibiotic for the condition to hit the market in decades.

The government-funded GARDP and Innoviva subsidiary shared phase 3 data assessing oral med zoliflodacin among 930 patients with uncomplicated gonorrhea across five countries—the largest clinical trial ever conducted for an investigational gonorrhea treatment, according to a Nov. 2 release from the two organizations.  

At day six, zoliflodacin met the statistical test for non-inferiority when compared to the current standard of care—an intramuscular injection of ceftriaxone and oral azithromycin—falling in at 5.31%, which is within the pre-specified margin of 12% and the FDA’s guidance of 10%.

The med was generally well tolerated, with no serious adverse events or fatalities observed.

“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 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.”

More than 82 million new gonorrhea infections occur every year worldwide, making it one of the most common sexually transmitted infections. As the antibiotic resistance crisis heightens, bacterium Neisseria gonorrhoeae has evolved to resist many classes of antibiotics, making ceftriaxone the only effective treatment currently recommended by health authorities.

Zoliflodacin is designed to inhibit type II topoisomerase, a bacterial enzyme necessary for bacterial function and reproduction, giving the drug the potential to tackle difficult-to-treat gonorrhea infections.

Swiss non-profit GARDP sponsored and led the phase 3 study and will have the right to register and commercialize the product in more than 75% of the world. Meanwhile, Entasis Therapeutics—an AstraZeneca spinout that Innoviva Specialty Therapeutics bought out in 2022—will hold commercial rights in certain North America, Europe, Asia-Pacific and Latin America markets.

Other investigational gonorrhea treatments in development include GSK’s phase 1/2 vaccine candidate, which received fast-track designation from the FDA this summer.