The P-III (CANDLE) study evaluating ibrexafungerp (300mg, BID) vs PBO in 260 female patients with RVVC. Patients initially received a 3-day regimen of fluconazole
The trial met its 1EPs i.e., 65.4% vs 53.1% of patients achieved clinical success with no recurrence at all either culture-proven, presumed, or suspected who received monthly single-day ibrexafungerp @24wks., superiority over PBO in 1EPs & 2EPs incl. no mycologically proven recurrence in 70.8%
In ITT & mITT population, 71% & 80% achieved a reduction or elimination of signs & symptoms, were safe & well-tolerated with no serious drug-related AEs, and no patients discontinued therapy due to AEs. The US FDA will review the sNDA of Brexafemme for an additional indication to prevent RVCC on Nov 30, 2022
Ref: SCYNEXIS | Image: SCYNEXIS
