Phase 3 drug study finds ‘unprecedented’ positive results

A global study of zoliflodacin, a drug candidate for gonorrhea, found “unprecedented” phase 3 results, its drugmaker said Nov. 1. 

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A specialty subsidiary of Innoviva and the Global Antibiotic Research & Development Partnership conducted the research into the pathogen deemed a priority by the World Health Organization. 

GARDP called the clinical trial “pivotal” and “unprecedented” as antimicrobial resistance rises.

“Study investigators found that oral zoliflodacin demonstrated statistical non-inferiority of microbiological cure at the urogenital site when compared to treatment with intramuscular  injection of ceftriaxone and oral azithromycin, a current global standard of care regimen,” the organization said in a news release.

If zoliflodacin is approved, it will be the first new gonorrhea antibiotic in decades. 

Gonorrhea is the third-most common sexually transmitted infection, and it affects 82 million people per year, according to GARDP.

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