Positive Results Announced in Largest Pivotal Phase 3 Trial of a First-in-Class Oral Antibiotic to Treat Uncomplicated Gonorrhea
- A Phase 3 study of oral zoliflodacin met the primary endpoint when compared against the combination of injectable ceftriaxone and oral azithromycin, a current international standard of care.
- Positive top-line study results are a significant milestone in the development of a first-in-class antibiotic against drug-resistant Neisseria gonorrhoeae, a high priority pathogen.
- Groundbreaking antibiotic research and development partnership model paves the way for development of other antibiotics to address impact of antimicrobial resistance (AMR).
This is the first study to address a
“This is a significant step forward in the treatment of gonorrhea, and also shows that GARDP’s public-private partnership model can play a crucial role in helping to fix the public health failure at the heart of the global AMR crisis,” said Dr. Manica Balasegaram, Executive Director of GARDP. “Despite the extremely high public health value, there has been a lack of investment to develop new drugs for gonorrhea. This zoliflodacin program demonstrates that it is possible to develop antibiotic treatments targeting multidrug-resistant bacteria that pose the greatest public health threat, and which may not otherwise get developed.”
With more than 82 million new gonorrhea infections occurring globally each year, gonorrhea is the third most common sexually transmitted infection, affecting both men and women in ways that can result in serious and permanent health consequences. The bacterium Neisseria gonorrhoeae has gradually developed resistance to many classes of antibiotics used to treat these infections and as a result, ceftriaxone, given as a single intramuscular injection, has become the last available recommended treatment for gonorrhea globally.
“The outcome of this study is a potential game changer for sexual health," said Edward W. Hook III, MD, Protocol Chair for the study and Emeritus Professor of Medicine at the
Recent reports (The Lancet Infectious Diseases) of emergent ceftriaxone-resistant infections have heightened the urgency for new antibiotics. Effective treatment options are essential to reducing the burden of disease for individuals, and to preventing the spread of highly drug-resistant gonorrhea globally. If left untreated, gonorrhea can also cause infertility in women, life-threatening ectopic pregnancies, and pelvic inflammatory disease.2
“The success of this study could have a profound effect on how physicians approach gonorrhea infections, as an oral alternative to an injection could improve patient access and compliance, as well as help reduce the increasing spread of antibiotic-resistant strains of the disease,” said
Zoliflodacin has a unique mechanism of action in the way that it inhibits a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. Previous in-vitro studies have shown that it is active against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin, with no cross-resistance with other antibiotics. Now, the positive results of this landmark Phase 3 trial confirm that zoliflodacin has the potential to tackle the most difficult-to-treat gonorrhea infections.
The Phase 3 trial enrolled a total of 930 patients with uncomplicated gonorrhea, including women, adolescents, and people living with HIV, making it the largest clinical trial ever conducted for a new treatment against gonorrhea infection, with 16 trial sites in regions with a high prevalence of gonorrhea across five countries, including
Zoliflodacin met the prespecified statistical test for non-inferiority when compared to ceftriaxone and oral azithromycin (5.31% (95%CI 1.38, 8.65%)). Non inferiority of zoliflodacin was demonstrated within the pre-specified margin of 12% and, furthermore, within the margin of 10% as specified in
GARDP has the right to register and commercialize 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. GARDP is committed to work with its partners and local health authorities in markets where zoliflodacin receives regulatory approval, to help remove access barriers to ensure treatment is available to address unmet medical needs while ensuring appropriate and sustainable use.
This GARDP-led trial was funded with support from the governments of
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