Innoviva announces positive results in Phase 3 trial of zoliflodacin

The company states: “The Global Antibiotic Research & Development Partnership, in collaboration with Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. announced that zoliflodacin, a first-in-class antibiotic, met its primary endpoint in an unprecedented global pivotal Phase 3 clinical trial. Study investigators found 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. 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 gonorrhea in decades.”