719. Susceptibility Testing of Oteseconazole (VT-1161) Against Clinical Isolates from Phase 3 Clinical Studies in Subjects with Recurrent Vulvovaginal Candidiasis

Abstract Background Oteseconazole (VT-1161) is a novel, investigational oral therapy that currently under FDA review for the treatment of recurrent vulvovaginal candidiasis (RVVC). Susceptibility testing was performed on all viable clinical isolates collected from three Phase 3 studies to determine susceptibility causative pathogens oteseconazole versus current standard care, fluconazole. Methods Vaginal cultures were obtained at screening and subsequent study visits throughout duration (approx. 48 Weeks) submitted central mycology laboratory fungal species identification storage. conducted in accordance with CLSI Reference Method Broth Dilution Antifungal Testing Yeast M27-Ed4. Results Candida albicans identified as primary pathogen 87% women RVVC presenting an acute infection, followed by C. glabrata (8%). Other non-albicans including; parapsilosis, tropicalis, krusei, dubliniensis, kefyr Saccharomyces cerevisiae responsible < 1% infections. A total 1910 collected. The MIC range, MIC50 MIC90 values against ≤ 0.0005 > 0.25, 0.002 0.06 µg/mL, respectively. In comparison, fluconazole were, 32, 0.25 8 µg/mL C.glabrata 0.03 0.125 2 Conclusion demonstrated very low most strains, including resistant isolates, aligning outcomes. MICs strains approximately 6-fold lower than Disclosures Mahmoud Ghannoum, PhD, Mycovia Pharmaceuticals (Grant/Research Support, Research Grant or Support) Thorsten Degenhardt, Ph.D, (Employee, Shareholder) Karen Person, M.S., Pharmaceuticals, Inc. (Employee)Mycovia (Employee) Stephen Brand,