Business
SCYNEXIS Presents Positive Data from Its Pivotal Phase 3 CANDLE Study of Oral Ibrexafungerp for Prevention of Recurrent Vaginal Yeast Infections During the 2022 IDSOG Annual Meeting
The CANDLE study met its primary endpoint, with 65.4% of patients with recurrent vulvovaginal candidiasis (RVCC) who received monthly single-day ibrexafungerp
About this update from Scynexis, Inc.
[{"type":"text","content":"The CANDLE study met its primary endpoint, with 65.4% of patients with recurrent vulvovaginal candidiasis (RVCC) who received monthly single-day ibrexafungerp treatment achieving clinical success with no recurrence at all, either culture-proven, presumed or suspected.Ibrexafungerp achieved statistically significant superiority over placebo in both primary and key secondary endpoints, including no mycologically proven recurrence in 70.8% of patients.In a nested sub-study of ibrexafungerp in RVVC patients who failed to respond to a three-day initial regimen of fluconazole, one-day treatment with ibrexafungerp achieved a substantial reduction or complete elimination of symptoms in 71% of patients. SCYNEXIS has submitted a supplemental New Drug Application (sNDA) for a label expansion to include the prevention of RVCC and anticipates final review by the U.S. Food and Drug Administration with a regulatory decision target date of November 30, 2022. JERSEY CITY, N.J., Aug. 04, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of positive outcomes from its global Phase 3 CANDLE study investigating the safety and efficacy of oral ibrexafungerp for prevention of recurrent vulvovaginal candidiasis (RVVC), also known as vaginal yeast infection. The results were presented during the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting being held in Boston August 4-6, 2022. “We are pleased to present these results from our pivotal CANDLE study demonstrating positive outcomes in RVVC patients,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “As the only fungicidal oral treatment for vaginal yeast infections, ibrexafungerp continues to demonstrate its ability to not only treat acute infections but also prevent recurrences of the disease. Importantly, in the nested sub-study ibrexafungerp also showed benefit to patients who failed to respond to multiple doses of fluconazole, illustrating its potential role in these difficult-to-treat infections.” The Phase 3 CANDLE study evaluated the efficacy and safety of oral ibrexafungerp compared to placebo in 260 female patients with RVVC, defined as three or more episodes of VVC in the previous 12 m...