2023-11-03 23:40:00
Scanning electron micrograph of the bacteria Neisseria gonorrhoeae, which causes gonorrhea.
Photo: National Institute of Allergy and Infectious Diseases (NIAID) of the United States.
A few days ago, the pharmaceutical company Innoviva Specialty Therapeutics and the Swiss non-profit organization Global Antibiotic Research & Development Partnership (GARDP), announced that the antibiotic they have been working on, which seeks to treat supergonorrhea infections, gave good results in a phase three clinical trial, also known as large-scale clinical trials. (You can read: Medications: Sanitas would have accepted one of the proposals made by Cruz Verde)
“This is an important step forward in the treatment of gonorrhea, and also demonstrates that GARDP’s public-private partnership model can play a crucial role in helping address the failure of gonorrhea,” said Manica Balasegaram, Executive Director of GARDP. public health at the center of the global antibiotic resistance crisis.”
But, before addressing the results of the antibiotic, it is important to review what supergonorrhea is, known in more technical terms as multidrug-resistant gonorrhea. The first thing to note, as the World Health Organization (WHO) says, is that gonorrhea is a sexually transmitted infection that represents a considerable public health problem. In 2020 alone, the Organization estimates that more than 80 million new cases were recorded. (You may be interested in: The elusive formula to regulate medications: a problem from Uribe to Petro)
However, the WHO warns, resistance to antimicrobials to treat gonococcus (Neisseria gonorrhoeae) began to be detected shortly after these drugs began to be used to treat the infection.
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That is why the WHO calls ultra-resistant gonococci that cannot be treated with the drugs that currently exist, including ceftriaxone, azithromycin and penicillin, the disease “supergonorrhea.”
Those who suffer from supergonorrhea infections have up to five times higher risks of transmitting HIV, can become sterile and, in women, can cause abortion in the first trimester of pregnancy. Additionally, in newborns, it causes serious ophthalmic infections with a high probability of causing blindness. (You can also read: Sugary drinks that begin to have a tax from today)
Therefore, in the announcement made by both companies, they noted that “these positive preliminary results offer hope to patients with this condition, especially given the increase in antibiotic resistance of current regimens.”
The phase three trial involved 930 patients with uncomplicated gonorrhea, including people living with HIV, “making it the largest clinical trial ever conducted for a new treatment against gonorrhea infection,” those responsible explained.
One group of patients was given a single oral dose of 3 g of zoliflodacin, while the other group was given the standard treatment consisting of an injection of ceftriaxone plus 1 g of oral azithromycin. According to Nature magazine, what the researchers found is that “zoliflodacin was just as effective in curing infections as standard drugs.” (You may be interested in: Sanitas, Cruz Verde and the medications that got out of hand)
According to Edward W. Hook III, Study Protocol Chair and Professor Emeritus of Medicine at the University of Alabama at Birmingham, “the result of this study may be a game-changer in the area of sexual health. In addition to the potential benefits for patients with infections with resistant strains of Neisseria gonorrhoeae, the potential absence of cross-resistance with other antibiotics and the oral route of administration will simplify the treatment of gonorrhea for clinicians worldwide.”
What’s coming now? The first step will be a review of the results of the phase three trial. If this stage is passed, companies will be able to request regulatory approval from the health authorities of the different countries in which they want to market the medicine.
According to the Swiss organization, GARDP has the right to register and market the product in more than three-quarters of the world’s countries, including all low-income countries, most middle-income countries and several high-income countries. (You can read: What does TransMiCable have to do with physical activity in Ciudad Bolívar?)
Finally, GARDP committed “to work with its partners and local health authorities in markets where zoliflodacin receives regulatory approval, to help remove barriers to access to ensure the treatment is available to address unmet medical needs, while ensuring appropriate and sustainable use.”
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