Scynexis released data from its pivotal Phase 3 CANDLE study of oral ibrexafungerp (BREXAFEMME) for the prevention of recurrent vulvovaginal candidiasis.
The antifungal ibrexafungerp is currently FDA-approved only for the treatment of vulvovaginal candidiasis (VVC), but data from Scynexis’ pivotal phase 3 trial also show encouraging results for the prevention of recurrent vulvovaginal candidiasis (RVVC), a condition for which there is currently no approved treatment.1
According to phase 3 results, ibrexafungerp successfully achieved significant superiority over placebo for the primary and secondary study endpoints. Scynexis will submit the data in a supplemental New Drug Application for ibrexafungerp oral tablets (BREXAFEMME®) to the FDA for approval as treatment for RVVC and anticipate a decision by the end of 2022.
The study comprised of 260 women who were experiencing RVVC, which is defined as 3 or more per year. All patients were given a 3-day regimen of open-label fluconazole and were then randomized to receive 300mg of ibrexafungerp 2 times daily for 1 day over a 6-month period, or a matching placebo 1 day per month over the same 6-month period.
Results showed 65.4% of patients receiving ibrexafungerp achieved clinical success by having no recurrence at all, either culture-proven, presumed or suspected, through week 24 compared to 53.1% of placebo-treated patients (p=0.02). The advantage of ibrexafungerp over placebo was sustained over the 3-month follow-up period and remained statistically significant (p=0.034).
Data were equally compelling for a subgroup of 24 patients that failed to respond to the initial 3-day regimen of fluconazole; for 71% of whom the 1-day treatment of ibrexafungerp substantially reduced or completely eliminated signs and symptoms.
The report indicated no serious drug-related adverse reactions and concluded ibrexafungerp to be generally safe and well-tolerated. Reported events included headaches and gastrointestinal events, which were mild and consistent with the existing drug label.