Innoviva's oral antibiotic, zoliflodacin, met its primary endpoint in the largest pivotal phase 3 trial to date of a potential first-in-class treatment for gonorrhea.
Study investigators found that oral zoliflodacin demonstrated statistical non-inferiority when compared to treatment with intramuscular injection of ceftriaxone and oral azithromycin — the current global standard of care — confirming that zoliflodacin has the potential to tackle the most difficult-to-treat gonorrhea infections.
The bacterium Neisseria gonorrhoeae has gradually developed resistance to many classes of antibiotics used to treat these infections and as a result, ceftriaxone has become the last available recommended treatment for gonorrhea globally. Innoviva's zoliflodacin, however, 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
The 930-patient clinical trial was led by the Global Antibiotic Research & Development Partnership (GARDP), a Swiss not-for-profit organization, in partnership with Innoviva Specialty Therapeutics, a subsidiary of California-based Innoviva. The trial was funded by several governments, including ministries in the UK, Germany, Japan, Netherlands and Switzerland, and builds on a phase 2 trial sponsored by the U.S. National Institute of Allergy and Infectious Diseases.
If approved, zoliflodacin will be the first new antibiotic for treating gonorrhea in decades.
Back in May, Innoviva's intravenous antibiotic, Xacduro, became the first new antibiotic to win FDA approval this year. The pathogen-targeted therapy just the OK for the treatment hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, offering new hope for critically ill patients who have limited treatment options.