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.
ENPNewswire-August 5, 2022--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
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Release date- 04082022 - JERSEY CITY, N.J. - SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, 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 months. All patients initially received a three-day regimen of fluconazole, and responders were randomized to receive either 300 mg ibrexafungerp BID or matching placebo one day a month, for six months. The primary endpoint was efficacy as measured by the percentage of subjects with clinical success at test-of-cure (24 weeks).
The study met its primary endpoint, with 65.4% of patients who received monthly single-day ibrexafungerp treatment achieving clinical success with no recurrence at all, either culture-proven, presumed or suspected, through Week 24, compared to 53.1% of placebo-treated patients (p=0.02). In addition, ibrexafungerp demonstrated superiority over placebo in preventing mycologically proven recurrence of RVVC through Week 24, a key secondary endpoint. No mycologically proven recurrence was...
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