For the first time in decades, a new antibiotic has proven effective against gonorrhea, the third most common sexually transmitted infection in the world, which is becoming increasingly “bad”. The molecule is called zoliflodacin and the hopes of the global scientific community are placed in it to stem the spread of the so-called “super-gonorrhea”, i.e. bacterial strains of Neisseria gonorrhoeae resistant to all (or almost all) known antibiotics. The positive results of the phase 3 clinical trial were recently released by the non-profit Global Antibiotic Research and Development Partnership (Gardp).
by Paola Arosio
Gonorrhea and super-gonorrhea
With something like 82 million new infections in a year (data referring to 2020), gonorrhea is considered byWorld Health Organization a public health priority. The N. gonorrhoeae bacterium can infect the urogenital tract, the anorectal region and the throat, and does not always give obvious signs. However, if left untreated, the infection can have serious consequences on fertility (in women it can give rise to inflammatory conditions of the pelvis, internal abscesses, risk of ectopic pregnancies and preterm births) and increase the risk of contracting and transmitting HIV.
by Celeste Ottaviani
The first weapon of defense is prevention, using a condom in every relationship in which the partner’s health status is not known (there is currently no vaccine). Also because over time N. gonorrhoeae has demonstrated an incredible ability to develop resistance to all the antibiotics used to eradicate it and for about ten years now strains have been isolated in various countries (renamed super-gonorrhea) which always respond even less so to the last arrow left on our bow, namely the combination of ceftriaxone and azithromycin. On the part of public health authorities, therefore, there is a well-founded fear that gonorrhea will become an incurable infection.
A promising new antibiotic
The first reaction to the data released by the non-profit Gardp on the effect of the new antibiotic zoliflodacin, therefore, can only be one of enthusiasm. It is an antimicrobial molecule with a new mechanism of action compared to other classes of antibiotics that have lost or are losing effectiveness against the gonorrhea bacterium: it interferes with the function of an enzyme (called type II topoisomerase) which regulates the degree of winding of the DNA double helix and which is essential for bacterial reproduction.
by Elvira Naselli
In the largest Phase 3 clinical trial of a new treatment for gonorrhea ever (involving 930 people with uncomplicated gonorrhea in Belgium, the Netherlands, South Africa, Thailand, the United States), zoliflodacin had the same efficacy of elective therapy ceftriaxone (by intramuscular injection) + azithromycin (orally). Furthermore, it was well tolerated and no serious adverse events or deaths were recorded. Based on these results of the clinical trial and on the activity data against multi-resistant strains, zoliflodacin is therefore a candidate as a tool to combat the most difficult to treat gonorrhea infections. Gardp says it is ready to submit the request for approval to the regulatory agencies.