Drug-Resistant Gonorrhea Cases Rising: Is This New Antibiotic Our Last Hope?

A novel antibiotic has the potential to address drug-resistant strains of gonorrhea.

Gonorrhea, a sexually transmitted infection (STI) that ranks second in terms of prevalence in the United States, has exhibited resistance to all antibiotics employed for its treatment, except a single remaining approved therapeutic option.

A recently developed antibiotic has demonstrated comparable efficacy to the currently prescribed therapy for gonorrhea, alleviating concerns among experts in public health about the rise of drug-resistant variants of this sexually transmitted illness.

Gonorrhea currently holds the rank of the 2nd most common sexually transmitted infection, i.e. (STI) in the United States. It has demonstrated resistance to all antibiotics utilized for its treatment except the recommended combination therapy. Ceftriaxone injections and a single dosage of azithromycin tablets are part of this therapy. 

In recent years, there have been concerning findings indicating that the efficacy of this collection of antibiotics may not endure against the rapidly changing disease for an extended period.

The results of a recent late-stage clinical trial that ended on Wednesday show that moxifloxacin, a new antibiotic, works just as well as ceftriaxone and azithromycin at treating superficial gonorrhea infections. The researchers developed the medicine through a collaborative effort between the Global Antibiotic Research and Development Partnership, a nonprofit organization based in Switzerland, and Innoviva Specialty Therapeutics, a company located in the United States.

According to Dr. Jeffrey Klausner, an infectious disease expert at the Keck School of Medicine at USC who was not part of the experiment, the introduction of Zoliflodacin provides a novel approach to treating gonorrhea and, if utilized judiciously, may serve as a preventive measure against the proliferation of drug-resistant diseases.

The potential antibiotic, which may potentially become the initial novel therapy for gonorrhea sanctioned in many decades, is projected to be available on the market by the year 2025.

According to the WHO's data, they projected that the yearly global occurrence of gonorrhea surpasses 82 million newly reported cases. In the United States, there has been a significant increase in sexually transmitted infections (STIs) due to the cumulative impact of reduced funding for state and local public health agencies over several decades. According to the CDC's data, there was a significant increase of 28% in the number of reported cases of gonorrhea in 2021, totaling 710,151 instances, as compared to the statistics documented in 2017.

Gonorrhea is transmitted via sexual contact and can infect the vaginal region, rectum, and throat as distinct sites of infection.

The CDC, i.e., Centers for Disease Control and Prevention, reports that the prevalence of sexually transmitted infections (STIs) is exceptionally high among teenagers and young adults. Additionally, there is a disproportionate occurrence of STIs among homosexual and bisexual males. If left untreated, gonorrhea can pose a potential threat to fertility and have severe consequences for women, including the development of pelvic inflammatory disease and ectopic pregnancy. The presence of the virus can also elevate the likelihood of HIV transmission.

In recent times, there has been a growing concern among global health authorities over the emergence of resistance in gonorrhea towards ceftriaxone and azithromycin. This situation has led to the reporting of instances of extremely drug-resistant gonorrhea in several countries.

In January, the Massachusetts Department of Public Health documented the initial two instances of gonorrhea within the United States that exhibited resistance or diminished efficacy toward five distinct categories of antibiotics. The administration of ceftriaxone successfully treated those instances; nonetheless, public health authorities noted that these cases served as an indicator for the advent of antibiotic-resistant strains capable of evading the effects of the mentioned medication.

Dr. Jeanne Marrazzo, the Director of the National Institute of Allergy and Infectious Diseases, emphasizes that highly antibiotic-resistant gonorrhea strains may require extensive treatment involving multiple antibiotics unless a novel treatment option emerges.

According to the speaker, using the kitchen sink method could overburden medical resources and increase the likelihood of promoting more microbial drug resistance towards the other antibiotics.

One potential concern is the potential for gonorrhea to become completely resistant to treatment, particularly in some individuals.

As per a spokeswoman from Innoviva, the business intends to expeditiously apply for antibiotic approval from the Food and Drug Administration. Innoviva anticipates a prompt evaluation process, wherein the Food and Drug Administration, i.e., FDA, is projected to render a conclusion within around six months.

Zoliflodacin stands out as a distinctive antibiotic with a unique mechanism of action that targets the bacterium causing gonorrhea. In the past, lab tests have shown that moxifloxacin can effectively fight resistant strains of gonorrhea that don't respond to ceftriaxone or azithromycin, as well as strains that are resistant to other antibiotics.

One limitation of moxifloxacin is its efficacy in treating gonorrhea infections in different anatomical regions. Specifically, prior phase two clinical research, which was published in 2018, revealed that zoliflodacin exhibited reduced effectiveness in addressing gonorrhea infections in the throat compared to its efficacy in the vaginal or rectal locations. Nevertheless, Marrazzo, who was one of the co-authors of the study mentioned above, asserted that such a discrepancy is frequently observed in the context of gonorrhea therapies.

According to Marrazzo, the presence of gonorrhea in the throat is likely to provide a significant challenge in our efforts to manage and contain the spread of gonorrhea in the future.

According to Dr. Margaret Koziel, the chief medical officer of Innoviva, the recent study of moxifloxacin showed promising outcomes within a limited cohort of individuals afflicted with rectal or throat infections.

According to Koziel, the business intends to initiate discussions with the FDA over the potential label indication for urogenital illness or uncomplicated gonorrhea.

Dr. Manica Balasegaram, the executive director of the Global Antibiotic Research and Development Partnership, which collaborates with Innoviva in the trial, asserts that zoliflodacin exhibits potential for maintaining its effectiveness against gonorrhea for an extended duration compared to prior treatments for this infection. This is attributed to the fact that moxifloxacin was explicitly designed as a therapeutic intervention for this sexually transmitted infection. Ceftriaxone and azithromycin are employed in the treatment of many illnesses, and their extensive usage increases the likelihood of gonorrhea developing resistance to these antibiotics.

Dr. Jean-Michel Molina, an expert in STI prevention at the University of Paris who was not affiliated with the clinical research, stated that the administration of the new medicine orally, as opposed to by intramuscular injection with ceftriaxone, confers a notable benefit.

Molina serves as the principal investigator for one of many ongoing clinical trials investigating the efficacy of a meningitis B vaccine in preventing gonorrhea. The individual expressed their anticipation of delivering conclusive findings from their experiment during a scholarly conference scheduled for 2024.

The recent study on moxifloxacin involved the participation of 930 individuals, including men, women, and adolescents, including those with HIV, who were diagnosed with uncomplicated gonorrhea. Researchers conducted the study at 16 trial sites in five countries: Belgium, the Netherlands, South Africa, Thailand, and the United States.

The researchers assigned the participants randomly to two treatment groups: one group administered a single oral dose of moxifloxacin. In contrast, the other group received a ceftriaxone injection and oral azithromycin.

The World Health Organization (WHO) has highlighted the rise of drug-resistant diseases as a significant worldwide public health concern, ranking them among the top 10 risks to humanity. Within this context, the WHO has specifically recognized gonorrhea as a priority pathogen.

The trial of moxifloxacin is a pioneering effort coordinated by a nonprofit organization to address a priority pathogen. The Global Antibiotic Research and Development Partnership, i.e., GARDP, initiated by the World Health Organization (WHO) in 2016, aims to advance novel antibiotics into the market. GARDP's endeavors signify a hopeful and significant advancement in the crucial endeavor to stimulate research and development of innovative antibiotics. Pharmaceutical corporations often exhibit limited interest in antibiotics due to their narrow profit margins.

According to Marrazzo, the treatment of gonorrhea should not be seen by many as the next Ozempic.

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