Gonorrhoea: zoliflodacin to the rescue

C&I Issue 12, 2023

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BY BÁRBARA PINHO | 20 DECEMBER 2023

A new antibiotic for gonorrhoea has performed well in a major clinical trial. If approved, zoliflodacin could halt the rise of drug-resistant infections.

The new drug was tested on 930 patients from Belgium, the Netherlands, South Africa, Thailand and the US. The promising results were announced by Innoviva Specialty Therapeutics and the Global Antibiotic Research & Development Partnership (GARDP), who are leading the effort to test and eventually commercialise the antibiotic.

‘This is really good news for gonorrhoea patients around the world,’ says Alison Luckey, Medical Lead for the zoliflodacin programme at GARDP. ‘It provides another arrow in the armoury of treatments for STIs and will hopefully improve STI management globally.’

In the clinical trials, researchers compared a single oral dose of zoliflodacin to the globally recognised standard of care (ceftriaxone combined with azithromycin) for the treatment of gonorrhoea and found that zoliflodacin was just as effective.

Caused by Neisseria gonorrhoeae bacteria, the disease is treated with antibiotics. However, the World Health Organization has warned that resistance to drugs used to treat gonorrhoea is increasing worldwide. Zoliflodacin is a promising new treatment because it inhibits enzymes that are important for bacterial survival in a different way to other antibiotics, bypassing resistance.

Next steps involve regulatory approvals, starting with the Food and Drug Administration in the US. Later on, Luckey says GARDP will focus on taking the new antibiotic to low- and middle-income countries around the world.

Michael Marks, from the London School of Hygiene & Tropical Medicine in the UK, who wasn’t involved in the trials, says zoliflodacin is a welcome new tool to treat the disease, but warns that the next steps should be taken cautiously. ‘History teaches us that if we are not careful, resistance will also develop to zoliflodacin and so we need to consider carefully how the drug is used and the surveillance systems that are put in place to monitor for emerging resistance.’