A new antibiotic to treat gonorrhoea may be on the horizon after a successful phase 3 trial of an oral pill, zoliflodacin, that was led and sponsored by a non-profit organisation.
The results were announced last week by the Global Antibiotic Research and Development Partnership (GARDP), which conducted the trial in collaboration with Innoviva Specialty Therapeutics.
So far, only top line results have been shared in a media release and the findings have not yet been published in a medical journal.
The gonorrhoea bacteria – Neisseria gonorrhoeae – has slowly grown resistant to many classes of antibiotics, leaving injectable ceftriaxone in combination with oral azithromycin as the last available recommended treatment for gonorrhoea globally.
This has heightened the urgency for new antibiotics, reports Health Policy Watch.
Zoliflodacin showed “statistical non-inferiority” when compared to the standard regimen – and is easier to administer, being just one pill.
Previous studies have shown the drug to be active against multi-drug resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin, with no cross-resistance with other antibiotics.
Non-profit ‘fix’
Gonorrhoea is one of the top three most common sexually transmitted infections with more than 82m new annual infections – mostly in Africa.
The WHO has designated gonorrhoea as a “priority pathogen”, yet no new treatments have been trialled in 40 years.
This is the first trial of a priority pathogen led by a non-profit organisation.
Professor Glenda Gray, GARDP board member and president of the South African Medical Research Council (SAMRC), said: “GARDP’s model can play a crucial role in helping to fix the public health failure at the heart of the global AMR crisis and is a significant step forward in the treatment of gonorrhoea.”
The trial enrolled 930 people with gonorrhoea in South Africa, Thailand, the United States, Belgium and the Netherlands. Participants received either zoliflodacin, given as a pill, or the disease’s standard treatment, an injection of an antibiotic called ceftriaxone, in combination with an oral dose of the antibiotic azithromycin.
None of the cases was caused by bacteria resistant to ceftriaxone or azithromycin, but the trial found that zoliflodacin was just as effective at curing infections as the standard drugs. The trial also found that the drug was safe and participants tolerated it well.
First-line treatment?
Professor Sinead Delany-Moretlwe, principal investigator for the trial in South Africa, said that the trial had been conducted under difficult circumstances during the height of the pandemic.
“The huge investment in HIV trial infrastructure has given South African scientists the capacity to do trials in infectious diseases and to yield results that can be submitted to a range of regulatory authorities,” she said.
While countries’ medicine regulators still need to grant approval for the drug, parties involved in the trial have discussed an implementation strategy – including whether zoliflodacin should be given as a first-line drug.
“Because it’s an easier drug to administer, if the cost is affordable, it makes sense to implement it (as a first-line treatment),” said Delany-Moretlwe, research director of Wits RHI.
Applying for approvals
“GARDP has the right to register and commercialise the product in more than three-quarters of the world’s countries, including all low-income countries, most middle-income countries, and several high-income countries,” said a GARDP spokesperson.
However, Innoviva affiliate Entasis Therapeutics has commercial rights for zoliflodacin in the lucrative markets of North America, Europe, Asia-Pacific and Latin America.
“Our aim is to provide sustainable access to an affordable product but we are unable to give further details as we move into negotiations with commercial partners,” a GARDP spokesperson told Health Policy Watch.
GARDP and Innoviva ST will apply for approval with the US Food and Drug Administration (FDA), and initiate registration activities in South Africa and Thailand shortly after FDA submission.
“Once approval is obtained in these two countries, we will expand access to zoliflodacin through a process of collaborative approvals within a number of countries,” said GARDP, depending on “the public health need and on the epidemiological situation in each country”.
See more from MedicalBrief archives:
South Africa in phase three trial to combat global gonorrhoea threat
GARDP: SA site activation in global phase 3 study of Zoliflodacin as gonorrhoea treatment
EU reports 17% rise in confirmed cases of gonorrhoea
New oral antibiotic successful with uncomplicated gonorrhoea