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Innoviva Specialty Therapeutics Announces Publication in The Lancet of Positive Zoliflodacin Phase 3 Data for the Treatment of Uncomplicated Urogenital Gonorrhea
Phase 3 findings show oral zoliflodacin to be non-inferior to the combination of ceftriaxone and azithromycin for the treatment of uncomplicated urogenital
About this update from Innoviva, Inc.
[{"type":"text","content":"\n\nPhase 3 findings show oral zoliflodacin to be non-inferior to the combination of ceftriaxone and azithromycin for the treatment of uncomplicated urogenital gonorrhea.\n\n\nPositive study results are a significant milestone in the development of a first-in-class single-dose, oral antibiotic against gonorrhea, including infections caused by drug-resistant Neisseria gonorrhoeae, an urgent public health threat and high-priority pathogen.\n\n\nGonorrhea is the second most reported bacterial STI in the United States, with resistance to first-line treatment emerging.1,2\n\n\n WALTHAM, Mass.--(BUSINESS WIRE)--\nInnoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), today 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 (GARDP).\n\n“Gonorrhea continues to be a significant public health concern worldwide, and the growing challenge of antimicrobial resistance only heightens the urgency for new treatment options,” said Dr. Edward (Ned) Hook, MD, Emeritus Professor of Medicine at the University of Alabama at Birmingham and protocol chair of the study. “The findings published today in The Lancet provide important evidence supporting the potential role of zoliflodacin as a novel, single-dose oral therapy for uncomplicated gonorrhea. These results represent a meaningful step forward in addressing the evolving landscape of gonococcal treatment.”\n\nMore 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.4 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.\n\n“Our study demonstrated the non-inferior efficacy of ...