Investigational antibiotic zoliflodacin promising treatment of uncomplicated gonorrhea
Antimicrobial resistance in Neisseria gonorrhoeae is a growing global health threat. Approximately 82 million new gonorrhoea infections occurring globally each year, gonorrhoea is the third most common sexually transmitted infection, affecting both men and women in ways that can result in serious and permanent health consequences.
Recently The Global Antibiotic Research & Development Partnership (GARDP) in collaboration with Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), announced that zoliflodacin, a first-in-class antibiotic, met its primary endpoint in an unprecedented global pivotal phase 3 clinical trial.
GARDP reports that oral zoliflodacin demonstrated statistical non-inferiority of microbiological cure at the urogenital site when compared to treatment with intramuscular (IM) injection of ceftriaxone and oral azithromycin, a current global standard of care regimen. In the study, zoliflodacin was found to be generally well tolerated and there were no serious adverse events or deaths recorded in the trial.
The phase 3 trial enrolled a total of 930 patients with uncomplicated gonorrhoea, including women, adolescents and people living with HIV, making it the largest clinical trial ever conducted for a new treatment against gonorrhoea infection, with 16 trial sites in regions with a high prevalence of gonorrhoea across five countries, including Belgium, the Netherlands, South Africa, Thailand, and the U.S. The trial compared a single oral suspension 3g dose of zoliflodacin to a globally recognized standard of care regimen (500mg ceftriaxone IM plus 1g oral azithromycin) for the treatment of uncomplicated gonorrhoea.
Researachers found that 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 U.S. Food and Drug Administration guidance.
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).
Researchers added “This is the first study to address a World Health Organization priority pathogen that has been sponsored and led by a non-profit organization. These positive preliminary findings offer hope for patients with this condition, particularly in the face of rising antibiotic resistance to current regimens. It also paves the way for a new research and development model in the global fight against antimicrobial resistance (AMR). If approved, zoliflodacin will be the first new antibiotic for treating gonorrhoea in decades.”
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