The incredibly drug-resistant “super gonorrhea” may have finally faced a foe it can’t best in the form of first-in-class antibiotic zoliflodacin. In a Phase III trial, the results of which were announced last week, the drug was found to treat the bacterial infection, making it the first new antibiotic in decades for targeting gonorrhea.
Gonorrhea is a sexually transmitted infection (STI) caused by the bacterium Neisseria gonorrhoeae. There are around 82 million new infections among adults globally each year, making it one of the most common STIs. While it is preventable and curable, it can lead to infertility and other sexual and reproductive health issues if left untreated.
Unfortunately, gonorrhea has steadily developed resistance to the array of antibiotics prescribed to treat it, hence the term “super gonorrhea” was coined to describe seemingly invulnerable strains. Super gonorrhea has proved resistant to basically every drug scientists have thrown at it, meaning there is now a dire need for novel treatments before the disease becomes untreatable.
Enter, zoliflodacin. The antibiotic, which targets a bacterial enzyme essential for cell function and reproduction, is being developed by Entasis Therapeutics, in collaboration with the non-profit Global Antibiotic Research and Development Partnership (GARDP). On November 1, GARDP announced the promising results of their Phase III trial.
“The outcome of this study is a potential game changer for sexual health,” Dr Edward W. Hook III, Protocol Chair for the study, said in a statement. “In addition to the potential benefits for patients with infections with resistant strains of Neisseria gonorrhoeae, the potential lack of cross-resistance with other antibiotics and the oral route of administration will simplify gonorrhoea therapy for clinicians worldwide.”
The trial, the largest ever conducted for a new treatment against gonorrhea, involved over 900 people with uncomplicated gonorrhea hailing from the US, Belgium, the Netherlands, South Africa, and Thailand. Participants were given either a single oral dose of zoliflodacin or a combination of ceftriaxone (intramuscular injection) and azithromycin (oral) – a standard treatment for the STI.
Zoliflodacin was found to be as effective as the current standard of care regimen, and was safe and well tolerated – results that are “certainly groundbreaking”, Magnus Unemo, a microbiologist at Örebro University Hospital in Sweden, told Nature.
“The success of this study could have a profound effect on how physicians approach gonorrhoea infections, as an oral alternative to an injection could improve patient access and compliance, as well as help reduce the increasing spread of antibiotic resistant strains of the disease,” Pavel Raifeld, Chief Executive Officer, Innoviva, Inc., explained.
For now, the trial results will need to be further validated and the drug approved by regulatory bodies before zoliflodacin makes its way to patients. GARDP holds the rights to commercialize the drug in most of the world and Entasis has a license for the major markets in the rest.
Then, of course, we’ll have to make sure the drug isn’t used and abused to prevent resistance against the first new gonorrhea antibiotic in decades from rising too rapidly.