Phase III FURI study of ibrexafungerp shows positive outcomes in vulvovaginal candidiasis.
Scynexis announced the presentation of new positive outcomes in patients with refractory vulvovaginal candidiasis (VVC) treated with oral ibrexafungerp from the ongoing Phase III FURI study.
Of the 14 patients in the FURI study with refractory or relapsed cases of VVC treated with ibrexafungerp, 10 (71.4%) had successful clinical outcomes as judged by an independent Data Review Committee. Patients with VVC received 750 mg of oral ibrexafungerp (375 mg twice a day) every 72 hours for a total of three dosing days (Day 1, Day 4 and Day 7).
The ongoing Phase III open-label, single-arm FURI study (NCT03059992) is evaluating oral ibrexafungerp for the treatment of patients with severe fungal infections who are either intolerant to standard antifungal therapy or experience refractory fungal infections despite treatment. In the study, ibrexafungerp was generally safe and well-tolerated with findings consistent with the existing Brexafemme (ibrexafungerp tablets) label.
Earlier this year, Scynexis also announced positive results from its global Phase III CANDLE study investigating the safety and efficacy of oral ibrexafungerp for prevention of recurrent vulvovaginal candidiasis (rVVC), also known as vaginal yeast infection. The Company plans to submit to the FDA a supplemental New Drug Application (sNDA) in the first half of 2022 based on the CANDLE data and anticipates receiving approval for a label expansion by year-end. The new interim analysis was presented during the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting held in San Diego on May 6-8, 2022.
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