Successful Phase 3 Zoliflodacin Trial Results for Gonorrhea Treatment Presented at ESCMID Global 2024

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., has announced the successful results of a Phase 3 trial for a novel antibiotic, zoliflodacin, developed in collaboration with the Global Antibiotic Research & Development Partnership (GARDP). The trial focused on treating uncomplicated gonorrhea, a sexually transmitted infection that has become increasingly resistant to conventional antibiotic treatments.

The Phase 3 study involved 930 patients, including women, adolescents, and individuals with HIV, across five countries with high rates of gonorrhea. The trial compared the effectiveness of a single 3g oral dose of zoliflodacin to the current global standard of care, which involves a combination of intramuscular ceftriaxone and oral azithromycin. The primary outcome measured was the microbiological response at the urogenital site post-treatment.

Zoliflodacin demonstrated a 90.9% microbiological cure rate, which was statistically non-inferior to the standard treatment. The trial also reported that zoliflodacin was well-tolerated, with a similar rate of adverse events as the standard treatment and no serious adverse events reported.

The results of this trial are significant as they indicate a potential new treatment option for gonorrhea that could improve patient compliance and potentially slow the spread of antibiotic-resistant strains. The findings will be presented at the European Society of Clinical Microbiology and Infectious Disease Global Congress in April 2024.

Gonorrhea is a significant global health concern, with the World Health Organization estimating 82 million new cases annually. The bacterium responsible for gonorrhea, Neisseria gonorrhoeae, has shown resistance to multiple antibiotic classes, leading to limited treatment options. Ceftriaxone, administered via intramuscular injection, has been the last recommended treatment worldwide.

GARDP, a not-for-profit organization, works to develop new antibiotic treatments for drug-resistant bacterial infections and make them accessible to those in need. The partnership between GARDP and Innoviva Specialty Therapeutics underscores the importance of public-private collaborations in addressing the global antimicrobial resistance crisis.

Innoviva Specialty Therapeutics is dedicated to providing innovative therapies in critical care and infectious disease. Their pipeline includes zoliflodacin, which has shown promise in treating uncomplicated gonorrhea in adults. The company's focus on developing new treatments for drug-resistant infections aligns with the urgent need to combat the spread of antibiotic resistance and improve global health outcomes.