Innoviva's zoliflodacin meets primary endpoint in Phase 3 gonorrhea trial

Innoviva, Inc.

Zoliflodacin met primary efficacy endpoint with non-inferiority to ceftriaxone+azithromycin in urogenital gonorrhea (point estimate 5.3% difference, 95% CI 1.4%-8.7%).
Microbiological cure rates >90% in both arms; 90.9% for zoliflodacin vs 96.8% for comparator in Micro-ITT population.
Secondary analyses at rectal and pharyngeal sites showed comparable cure rates but were not powered for statistical significance.
Safety profile favorable: no serious AEs, discontinuations, or deaths; headache (9.9%) most common TEAE for zoliflodacin.
Global Phase 3 trial enrolled 927 patients across 16 sites in US, South Africa, Belgium, Netherlands, and Thailand.

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