First drug proven effective in decades

We live in the golden age of sexually transmitted infections. With the exception of HIV, they have all been increasing uncontrolled for years, especially gonorrhea, whose cases are exploding in Spain. At the same rate, their resistance to current antibiotics is also increasing. However, there is an open door of hope: a trial of a new drug, promoted by an NGO, offers First positive result after a long time,

To contextualize the problem: In 2020, 82.4 million new cases of the bacterial disease gonorrhea were reported in the world. Neisseria gonorrhoeae, WHO aims to reduce that figure to 8.23 ​​million in 2030, but faces a serious problem, the outbreak of resistant strains. In fact, More and more cases of ‘supergonorrhea’, as it is called when conventional treatments no longer respond, are being reported.,

This resistance has been spreading since the 1980s. Associations of tetracyclines, sulfonamides and trimethoprim or quinolones have already succumbed to new strains found in Japan, Australia, France, the United Kingdom or Sweden.

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The standard therapy today is ceftriaxone in combination with azithromycin. But cases of resistance have already been reported in Denmark, France, Japan and the United Kingdom.

Although most cases in the world occur in Africa, Infection rates have increased in the EU in recent years, Spain has a special role: after a decline in the number of cases at the end of the last century, there has been an unstoppable increase since 2002.

According to the latest available 2021 report on epidemiological surveillance of sexually transmitted infections in Spain, from the Carlos III Health Institute, the number of cases has increased 20-fold over the next 20 years. The current figures are 15,338 notifications and a recovery rate of 32.41. Cases per 100,000 Spaniards.

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“This is an infection that is increasing not only in the population of men who have sex with other men,” he warned. Jordi Casabona“But also in heterosexual and young populations, especially adolescents,” said the spokesperson for the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC).

This is not a fatal disease but if it is not treated properly then it can become a fatal disease. Serious problems, “especially in women”, Infertility, ectopic pregnancies and miscarriages, but also inflammation that can cause acute and long-term pain, as well as increased HIV transmission.

With this panorama in mind, a few years ago the first antibiotics in decades came out to treat gonococcal infections. It is called zoliflodacin and was initially developed by Entasys Therapeutics, a subsidiary of AstraZeneca.

Alliance between an NGO and a pharmaceutical company

In 2018, a study on 179 people funded by the United States Institute of Public Health produced good results, but the clinical development of this drug stopped there. The small size of the trial was not enough to qualify for regulatory approval.

Five years passed until the drug received a new boost from the Swiss non-profit organization Global Antibiotic Research and Development Partnership (GARDP), which this time teamed up with Entasys to conduct a new trial. 930 people suffering from gonorrhea from South Africa, Thailand, United States, Belgium and Netherlands,

The patients were divided into two groups: one was given zolidoflucin and the other ceftriaxone. The experimental drug was as effective as standard therapy in curing the infection. Furthermore, it was as safe and well tolerated as ceftriaxone.

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None of the cases in the study were caused by strains resistant to current antibiotics, but laboratory experiments showed they are sensitive to the new drug. Be careful: cases of development of resistance to zoliflodacin have also been observed, but, equally, only in the laboratory.

“Insects adapt rapidly,” explains Casabona. “When treatments are used extensively, incorrectly and consistently, they select for bacteria that survive. That’s why we must have very well-defined treatment guidelines.”

The expert emphasizes the latter: Any antibiotic, no matter how good, can develop resistance if used incorrectly, “The criteria for use of this future drug must be well defined.”

However, Casabona is optimistic. “This is news that the scientific and medical community is looking forward to,” he says. Additionally, and this is very important to them, “it has been promoted by a non-profit consortium in collaboration with the pharmaceutical industry, Which should facilitate its commercialization.”

In cases of rare diseases or those that mainly affect low-income countries, low economic interest has caused many large pharmaceutical companies to cancel projects. That’s why this partnership with GARDP is so important, “This is a model that can be used to develop other products” by facilitating clinical trials – which cost more – when capital is reluctant.

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