South Africa is one of five countries involved in a phase three trial to develop a first-in- class antibiotic for gonorrhoea – one of the three most common sexually transmitted infections in the world, which has serious consequences if left untreated but which has limited treatment options due to antimicrobial resistance.
Gonorrhoea is rising rapidly across around the globe, with 82m new cases estimated annually, and in South Africa, 2m new infections every year, so the new trial offers much cause for optimism, notes MedicalBrief.
The Global Antibiotic Research & Development Partnership (GARD`gP) and Innoviva Specialty Therapeutics, a subsidiary of Innoviva, last week announced the completion of recruitment for their global phase three pivotal registration trial of oral zoliflodacin, an investigational antibiotic being developed to treat uncomplicated gonorrhoea.
GARDP is a Swiss NPO developing new treatments for drug-resistant infections that pose the greatest threat to health, created by the WHO and the Drugs for Neglected Diseases initiative (DNDi) in 2016. It is funded by the Governments of Australia, Germany, Japan, Monaco, the Netherlands, South Africa, the Public Health Agency of Canada, Switzerland, the UK, the Canton of Geneva, as well as the European Union, Wellcome Trust and private foundations.
“Completing the recruitment marks a significant milestone as it is the first antibiotic trial fully funded and sponsored by a non-profit like the Global Antibiotic Research & Development Partnership,” said Dr Manica Balasegaram, GARDP’s executive director. “It brings us one step closer to developing a new treatment for gonorrhoea, which is rapidly becoming resistant to existing antibiotics.”
In 2017, GARDP partnered with Entasis Therapeutics Limited, now a subsidiary of Innoviva Specialty Therapeutics, to carry out the phase three trial at 16 sites across five countries (South Africa, Belgium, the Netherlands, Thailand and the US), comparing zoliflodacin to a globally recognised regimen (500mg ceftriaxone plus 1g azithromycin) for the treatment of uncomplicated gonorrhoea.
The first patient was recruited in the US in November 2019, and the trial continued, despite obstacles, throughout the pandemic. A total of 958 patients were recruited, making it the largest clinical trial ever conducted for a new treatment against gonorrhoea infection.
The top-line results of the phase three registrational trial are expected later this year.
Under the collaboration agreement with Entasis, GARDP has the rights to register and commercialise zoliflodacin upon approval in more than 75% of all countries worldwide, including all low-income, most middle-income, and a number of high-income countries. Innoviva retains commercial rights for zoliflodacin in the major markets in North America, Europe, Asia-Pacific, and Latin America.
“Completion of study enrolment allows us to move forward to better understand how zoliflodacin may work to tackle the ongoing threat of progressive gonococcal antimicrobial resistance,” said Dr Edward Hook, Emeritus Professor of Infectious Disease at the University of Alabama, and Global Protocol Chair for the zoliflodacin trial.
“We hope this novel approach will yield an oral alternative to currently recommended therapy, which can only be administered by injection.”
Gonorrhoea affects both men and women, particularly those aged 15-24. Recent outbreaks of extensively drug-resistant gonorrhoea to the last-line treatment option have been reported in the US and the UK.
If left untreated, it can have serious and permanent consequences, especlally for women, including infertility, life-threatening ectopic pregnancies and pelvic inflammatory disease.
It is caused by the bacterium Neisseria gonorrhoeae, which has progressively developed resistance to globally recommended treatments and has been identified by the WHO as a “priority pathogen” posing one of the greatest threats to global health.
See more from MedicalBrief archives:
GARDP: SA site activation in global phase 3 study of Zoliflodacin as gonorrhoea treatment
Declining susceptibility to azithromycin found in German gonorrhoea samples
Throat a major source of gonorrhoeal infection in MSM
EU reports 17% rise in confirmed cases of gonorrhoea