The investigational antibiotic zoliflodacin is showing promise as a potential treatment for uncomplicated gonorrhea, including resistant strains. Topline data from a Phase 3 trial revealed the drug's efficacy and safety, positioning it as a potential solution to the growing challenge of antibiotic-resistant gonorrhea. Innoviva Specialty Therapeutics is preparing to file for FDA approval in the first quarter of next year.
The Centers for Disease Control and Prevention (CDC) estimates that 2.5 million cases of syphilis, gonorrhea, and chlamydia occurred in 2021, up from 2.4 million in 2020, highlighting the increasing incidence of STIs in the US. The emergence of multidrug-resistant strains of Neisseria gonorrhoeae, particularly those with the penA 60.001 allele, further complicates treatment efforts. This allele reduces the bacteria's susceptibility to cephalosporins, a class of last-resort drugs.
Phase 3 Trial Results
The global, randomized, controlled Phase 3 trial evaluated the efficacy and safety of zoliflodacin as a single-dose oral treatment. The results, previously disclosed at the European Society of Clinical Microbiology and Infectious Disease (ESCMID) 2023, indicated that zoliflodacin was non-inferior to a combination of ceftriaxone and azithromycin.
Urogenital microbiological cure rates were 90.9% (88.1-93.3) in the zoliflodacin arm and 96.2% (92.9-98.3) in the ceftriaxone/azithromycin arm, demonstrating a difference of 5.31% (95% confidence interval: 1.38-8.65). The safety profile of zoliflodacin was favorable, with a comparable number of adverse events between the treatment groups.
Addressing Unmet Needs
According to Innoviva Specialty Therapeutics CMO David Altarac, MD, the company is focused on developing zoliflodacin specifically for uncomplicated gonorrhea. "We believe that, as we've done with other products, a focus on targeted development will advance the efforts towards developing products that have specific focus will be used responsibly, and will hopefully increase the longevity of that product," he stated.
With the Phase 3 results in hand, Innoviva is targeting a New Drug Application (NDA) submission to the FDA in the first quarter of next year. Zoliflodacin has already received Qualified Infectious Disease Product (QIDP) and Fast Track designation from the FDA, potentially expediting the review process. If the NDA is accepted, the company will aim for a priority review.
