Scientists have made a significant discovery in the battle against super gonorrhea. In a recent large-scale clinical trial, the experimental drug zoliflodacin proved to be just as effective as other frontline antibiotics in treating this stubborn bacterial infection. These findings pave the way for zoliflodacin to become an essential tool in the ongoing fight against antibiotic resistance.
Gonorrhea, caused by the bacteria Neisseria gonorrhoeae, is one of the most commonly reported sexually transmitted infections worldwide. While not everyone who contracts it will become ill, its symptoms can be quite distressing, including discolored genital discharge, painful urination, swollen testicles in males, and abnormal bleeding between menstrual periods in females. Left untreated, it can lead to infertility, increase the risk of acquiring other STIs, and even cause blindness in infants infected during birth.
At one time, gonorrhea was easily treatable with penicillin, but the bacteria has progressively developed resistance to nearly all commonly used antibiotics. More recently, cases of gonorrhea that are resistant to even the last remaining drugs have emerged. While there are many other drug-resistant strains of bacteria, gonorrhea may become one of the first superbugs to spread widely in communities in the near future.
The crisis of antibiotic resistance has prompted scientists and research organizations to urgently develop new drugs to combat infections like gonorrhea. These drugs should not only be effective, but also target infections in a different way than existing antibiotics, delaying the development of resistance. Zoliflodacin appears to meet both of these criteria.
The non-profit organization Global Antibiotic Research & Development Partnership (GARDP), along with Entasis Therapeutics, an affiliate of Innoviva, is developing this drug. In their latest and largest study, a Phase III clinical trial, GARDP revealed the results of zoliflodacin.
The trial enrolled over 900 individuals in five countries, including the U.S., diagnosed with uncomplicated gonorrhea. These patients were randomly assigned to receive a single oral dose of zoliflodacin or a combination of the antibiotics ceftriaxone and azithromycin, a common frontline treatment (some countries, like the U.S., now recommend only using ceftriaxone due to increasing azithromycin resistance).
The trial successfully demonstrated that zoliflodacin effectively cleared the infection, comparable to ceftriaxone and azithromycin. The drug was also well-tolerated, with no serious adverse events or deaths reported. Further research has shown that zoliflodacin utilizes a unique mechanism to kill gonorrhea bacteria and can combat drug-resistant strains, making these results even more promising.
Edward W. Hook III, protocol chair of the study and an emeritus professor of medicine at the University of Alabama, stated, “The outcome of this study is a potential game changer for sexual health,” in a statement provided by GARDP. “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 gonorrhea therapy for clinicians worldwide.”
Although the findings must still undergo scrutiny from external scientists and regulatory agencies, zoliflodacin is likely to receive expedited approval as the first new drug for gonorrhea in decades. The drug has also shown promise as a treatment for other STIs such as chlamydia.
GARDP has acquired commercialization rights for the drug in three-quarters of the world, including many low- to middle-income countries. Entasis will hold rights in the remaining major markets, including the U.S. This distribution strategy aims to ensure that zoliflodacin is affordable in the areas where it is most needed. Additionally, careful consideration must be given to rationing the drug and using it only when other treatments are ineffective to maintain low levels of resistance.
Manica Balasegaram, executive director of GARDP, emphasized the importance of global access to this treatment, stating, “We cannot deprive people who need this treatment around the world,” in an interview with Nature.
