Innoviva and GARDP reveal positive results for antibiotic to treat gonorrhoea

Zoliflodacin inhibits the vital bacterial enzyme for bacterial function and reproduction

Innoviva Specialty Therapeutics and the Global Antibiotic Research and Development Partnership (GARDP) have announced positive results from a phase 3 trial of a first-in-class antibiotic, zoliflodacin, to treat uncomplicated gonorrhoea.

If approved, zoliflodacin will be the first new antibiotic treatment for gonorrhoea seen in decades.

Gonorrhoea is the third most common sexually transmitted infection, responsible for over 82 million new cases globally every year.

Over time, the Neisseria gonorrhoeae bacterium found in the infection has slowly developed resistance to many classes of antibiotics.

The trial met its primary endpoints after comparing a single, oral, 3g dose of zoliflodacin to a globally recognised standard care regimen (a 500mg intramuscular injection of ceftriaxone plus 1g oral azithromycin) in 930 patients with uncomplicated gonorrhoea.

The patients included women, adolescents and people living with HIV across 16 trial sites in regions with a high prevalence of gonorrhoea in Belgium, the Netherlands, South Africa, Thailand and the US.

The antibiotic candidate demonstrated statistical non-inferiority of microbiological cure at the urogenital site when compared to standard care.

Additionally, zoliflodacin was found to be generally well tolerated, with no serious adverse events or deaths recorded in the trial.

Zoliflodacin works by inhibiting a crucial bacterial enzyme known as type 2 topoisomerase, which is vital for bacterial function and reproduction.

The positive preliminary findings show promise for patients with the condition and pave the way for a new research and development model to combat the global threat of antimicrobial resistance (AMR).

Dr Manica Balasegaram, executive director of GARDP, said that zoliflodacin “demonstrates that it is possible to develop antibiotic treatments targeting multidrug-resistant bacteria that pose the greatest public health threat”.

Pavel Raifeld, chief executive officer of Innoviva, said: “This study could have a profound effect on how physicians approach gonorrhoea infections… improve patient access and compliance, as well as help reduce the increasing spread of antibiotic-resistant strains of the disease.”