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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 show no symptoms, but in others, gonorrhea can lead to painful joints and burning while urinating. If left untreated, it can cause infertility and infertility, blindness in infants, or even death.
Over the years, the bacteria has found a way to evade almost every antibiotic available. It has become resistant to azithromycin and is becoming increasingly resistant to another antibiotic called ceftriaxone, which is now the standard treatment.
The most powerful defense combines an injection of ceftriaxone with azithromycin, but there is evidence that gonorrhea evolves to evade even that treatment.
Zoliflodacin is a new type of antibiotic, which raises the hope that the bacteria will remain susceptible to it for a long time.
“This is a new drug that really solves a problem that really needs to be solved,” says Dr. Manica Balasegaram, executive director of Global Antibiotic Research & Development Partnership, or GARDP, a nonprofit organization that oversaw the drug’s development.
“This doesn’t happen often,” he added.
The backstory: a clever way to create new antibiotics.
Pharmaceutical companies have largely given up on antibiotic development as unprofitable. The development of zoliflodacin represents a new model: GARDP, which is funded by numerous groups from 20 countries and the European Union, developed the drug in collaboration with an American pharmaceutical company called Innoviva Specialty Therapeutics.
The nonprofit sponsored the drug’s Phase 3 trial. In return, it has the license to sell the antibiotic in about 160 countries, while Innoviva retains marketing rights for high-income countries.
“I’ll go a step further and say this is probably the only way we can develop antibiotics in the future, because the old model is simply not going to work,” said Ramanan Laxminarayan, a senior researcher at Princeton University and chairman of the GARDP sign.
The agreement ensures that the antibiotic will be available and affordable to people in low- and middle-income countries.
“No one makes a lot of money treating gonorrhea, especially if you use a single dose of an oral antibiotic,” says Dr. Jeanne Marrazzo, director of the National Institute of Allergy and Infectious Diseases.
“This is a step forward to solve the dilemma of finding routes 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 930 people in five countries, the largest to date for a gonorrhea treatment. This showed that zoliflodacin was as effective in treating gonorrhea as the combination of ceftriaxone and azithromycin.
The trial was designed to test how well zoliflodacin works in the urogenital tract. Based on previous research, the drug is unlikely to be equally effective in the throat and rectum, Dr. Marrazzo said. But “this will give us a way to at least address very common infections, especially in women, worldwide,” she said.
The drug makers were more optimistic. The number of throat and rectal infections was too small to provide firm results, “but we are very encouraged because they were comparable” to the urogenital tract, said Dr. Margaret Koziel, Innoviva’s chief medical officer.
What now? Scientists will try to prevent resistance.
The more widely a drug is used, the more likely pathogens will find ways to defend themselves against it. Studies show that zoliflodacin is effective against a wide range of drug-resistant gonorrhea strains.
But that doesn’t rule out the possibility that the bacteria could still evolve to evade the drug. The partnership’s agreement minimizes that chance: The nonprofit plans to manage how the drug is distributed and ensure it is only used to treat gonorrhea.
