Scynexis Inc SCYX has announced results from its Phase 3 CANDLE study of oral ibrexafungerp to prevent recurrent vulvovaginal candidiasis (rVVC), also known as vaginal yeast infection.
- The Company plans to submit a supplemental marketing application to prevent rVVC in 1H of 2022 with anticipated approval by the end of the year.
- The 260-subject study showed that 65.4% of patients receiving ibrexafungerp achieved clinical success by having no recurrence at all through Week 24 compared to 53.1% of placebo-treated patients.
- Related: Scynexis' Brexafemme For Vaginal Yeast Infections Secures 10 Years Regulatory Exclusivity.
- The advantage of ibrexafungerp over placebo was sustained over the three-month follow-up period and remained statistically significant.
- The study also evaluated an additional group of 24 patients who failed to respond to the initial three-day fluconazole regimen and received a one-day open-label treatment course of ibrexafungerp (300 mg BID).
- 71% of ibrexafungerp treated patients achieved a significant reduction or elimination of signs and symptoms.
- Ibrexafungerp is the only fungicidal oral treatment for vaginal yeast infections and received FDA approval in June last year.
- Price Action: SCYX shares are down 0.77% at $5.13 during the market session on the last check Thursday.
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