Innoviva Publishes Positive Phase 3 Trial Results for Zoliflodacin

Innoviva Specialty Therapeutics "announced the publication of positive results from a pivotal Phase 3 trial evaluating its investigational single-dose, oral antibiotic zoliflodacin for the treatment of uncomplicated urogenital gonorrhea in The Lancet. The trial was sponsored and led by the Company's not-for-profit partner, the Global Antibiotic Research & Development Partnership. More than 82 million new gonorrhea infections occur globally each year, which, if left untreated, can result in serious and permanent health consequences.3 The emergence and spread of drug-resistant infections have led the World Health Organization to identify antimicrobial resistance as one of the ten most critical global health threats. The bacterium Neisseria gonorrhoeae has developed resistance to most classes of antibiotics used to treat these infections, including cephalosporins such as ceftriaxone, an injectable treatment, which is the only recommended antimicrobial class for treating uncomplicated gonorrhea. Zoliflodacin study endpoints met the prespecified criteria for non-inferiority when compared to ceftriaxone and azithromycin (difference of 5.31% (95% CI 1.38%, 8.65%)) for the treatment of uncomplicated urogenital gonorrhea. Zoliflodacin was generally well tolerated and adverse events were comparable between treatment groups. No serious adverse events were reported."