Why it matters: Gonorrhea is a major global problem.
With more than 82 million new infections recorded worldwide in 2020, gonorrhea is one of the most common sexually transmitted diseases. The pathogen, Neisseria gonorrhoeae, spreads through sexual contact to the genitals, rectum and throat.
About half of infected people have no symptoms, but in others, gonorrhea can cause joint pain and burning when urinating. Untreated, it can cause infertility and sterility, blindness in infants, and even death.
Over the years, the bacteria has found a way to avoid almost all available antibiotics. He has become resistant to azithromycin and is increasingly resistant to another antibiotic called ceftriaxone, which is now the standard of care.
The most powerful defense combines an injection of ceftriaxone and azithromycin, but some evidence suggests that gonorrhea progresses to bypass even this treatment.
Zoliflodacin is a new type of antibiotic, which gives hope that the bacteria will remain sensitive to it for a long time.
“This is a new drug that really solves a problem that really needs to be solved,” said Dr. Manica Balasegaram, executive director of the Global Antibiotic Research & Development Partnership, or GARDP, a nonprofit organization that has oversaw the development of the drug.
“It doesn’t happen often,” he added.
The story: A clever way to create new antibiotics.
Pharmaceutical companies have largely abandoned the development of antibiotics, deemed unprofitable. The development of zoliflodacin represents a new model: GARDP, funded by many Group of 20 countries and the European Union, developed the drug in collaboration with an American pharmaceutical company called Innoviva Specialty Therapeutics.
The nonprofit sponsored the phase 3 trial of the drug. In exchange, it holds the license to sell the antibiotic in around 160 countries while Innoviva retains marketing rights for high-income countries.
“I’m going to go out on a limb and say that this is probably the only way to develop antibiotics in the future, because the old model just won’t work,” said Ramanan Laxminarayan, a senior researcher at Princeton University. and Chairman of the GARDP Board of Directors.
The agreement ensures that the antibiotic will be available and affordable to people in low- and middle-income countries.
“No one makes a ton of money treating gonorrhea, especially when you use a single dose of an oral antibiotic,” said Dr. Jeanne Marrazzo, director of the National Institute of Allergy and Infectious Diseases.
“This is a way forward to resolve the dilemma of finding channels for products that do not guarantee profits,” said Dr. Marrazzo.
What we don’t know: The drug may not cure all cases.
The clinical trial involved 925 people in five countries, the largest so far for a gonorrhea treatment. It showed that zoliflodacin was as effective in treating gonorrhea as the combination of ceftriaxone and azithromycin.
The trial was designed to test the effectiveness of zoliflodacin in the urogenital tract. Based on previous research, the drug is unlikely to be as effective in the throat and rectum, Dr. Marrazzo said. But “it will give us a path to at least address very common infections, particularly among women, around the world,” she said.
Drugmakers were more optimistic. The number of infections in the throat and rectum was too low to produce firm results, “but we are very encouraged because they were comparable” to those in the urogenital tract, said Dr. Margaret Koziel, Innoviva’s chief medical officer. .
And then: Scientists will try to prevent resistance.
The more widely a drug is used, the greater the chance that pathogens will find ways to defend themselves against it. In studies, zoliflodacin appears to be effective against a wide range of resistant strains of gonorrhea.
But that doesn’t rule out the possibility that the bacteria could evolve to dodge the drug. The partnership agreement minimizes this risk: the nonprofit plans to manage how the drug is distributed and ensure that it is used only to treat gonorrhea.