Oral Gonorrhea Treatment Study Proceeds

Without an approved vaccine preventing gonorrhea infections, there is significant demand for innovative treatments for millions of people each year.

To meet that need, the Global Antibiotic Research & Development Partnership (GARDP) and Innoviva Specialty Therapeutics today announced the completion of recruitment for their global phase 3 pivotal registration trial of oral zoliflodacin, an investigational, first-in-class antibiotic being developed for the treatment of uncomplicated gonorrhoea infection in patients.

The top-line results from this phase 3 trial are expected in Q4 of 2023.

In 2017, GARDP partnered with Entasis Therapeutics Limited to conduct a study at 16 sites across Belgium, the Netherlands, South Africa, Thailand, and the U.S., comparing zoliflodacin to a globally recognized regimen (500mg ceftriaxone plus 1g azithromycin) for the treatment of uncomplicated gonorrhoea.

The first patient was recruited in the U.S. in November 2019, and the trial continued, despite obstacles, throughout the recent pandemic.

A total of 958 patients were recruited, making it the largest clinical trial ever conducted for a new treatment against gonorrhoea infection.

“Completion of study enrollment allows us to move forward to better understand how zoliflodacin may work to address the ongoing threat of progressive gonococcal antimicrobial resistance in patients,” said Dr. Edward W. Hook III, Emeritus Professor of Infectious Diseases at the University of Alabama at Birmingham, and Global Protocol Chair for the zoliflodacin trial, in a press release on May 23, 2023.

“It is our hope this novel approach will yield an oral alternative to currently recommended therapy, which can only be administered by injection.”

Gonorrhoea is among the three most common sexually transmitted infections, and it affects men and women, particularly ages 15-24 years old.

Globally, the infection rate of gonorrhoea is increasing, with 82 million new cases estimated each year and minimal treatment options due to antimicrobial resistance.

The U.S. CDC announced on April 11, 2023, gonorrhoea rates increased by more than 4% last year, reaching 710,151 in 2022. 

In addition, recent outbreaks of extensively drug-resistant gonorrhoea to the last-line treatment option have been reported in the U.S. and the U.K.

Gonorrhoea can have serious and permanent consequences, particularly for women, including infertility, life-threatening ectopic pregnancies, and pelvic inflammatory disease.

Gonorrhoea is caused by the bacterium Neisseria gonorrhoeae, which has progressively developed resistance to globally recommended treatments and has been identified by the World Health Organization as a “priority pathogen,” posing one of the greatest threats to global health.

As of May 24, 2023, no approved gonerrhoea vaccine is available.

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