A phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of once monthly oral ibrexafungerp for prevention of recurrent vulvovaginal candidiasis (VVC)

Oral ibrexafungerp was recently approved for the treatment of acute vulvovaginal candidiasis (VVC). We report here the results from a Phase 3 study of ibrexafungerp given once a month for the prevention of recurrent VVC. Eligible patients (with recurrent VVC) who had culture-confirmed Candida spp. at baseline were randomized 1:1 to oral ibrexafungerp 300 mg BID for a single-day, or placebo. Ibrexafungerp and placebo treatments were repeated once every 4 weeks for a total of 6 single-day treatments. Efficacy was measured by the percentage of patients with no mycologically proven, presumed or suspected recurrence (all randomized ITT subjects) at Week 24, 4 weeks after the last dose. Subjects were further assessed for an additional 12 weeks to Week 36 for VVC recurrence. Efficacy was also assessed in the per-protocol population (patients who were culture positive at baseline and had no mycologically proven recurrence at Weeks 24 and 36). Subjects were randomized to ibrexafungerp or placebo. The results for the ITT (primary analysis) and the per-protocol (key secondary) populations are listed in the Table. Common adverse events in the ibrexafungerp group were gastrointestinal intolerance and headache. This study demonstrated that once a month ibrexafungerp has potential efficacy as a once-monthly treatment in the prevention of recurrent VVC.