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SCYNEXIS Pivotal Phase 3 VANISH-306 Trial Results Published in the International Journal of Obstetrics and Gynaecology (BJOG) Demonstrate Statistical Superiority of BREXAFEMME® (Ibrexafungerp Tablets) Over Placebo for Vaginal Yeast Infection
Patients receiving one-day treatment with oral ibrexafungerp had significantly higher rates of clinical cure, mycological eradication, and clinical
About this update from Scynexis, Inc.
[{"type":"text","content":"Patients receiving one-day treatment with oral ibrexafungerp had significantly higher rates of clinical cure, mycological eradication, and clinical improvement at Day-10 compared to placebo-treated patients. Ibrexafungerp demonstrated sustained clinical effect at Day-25 follow-up with 73.9% of treated patients achieving a complete resolution of signs and symptoms.The Phase 3 VANISH clinical trial program (VANISH-303 and VANISH-306) supported the approval of BREXAFEMME by the U.S. Food and Drug Administration (FDA) in June 2021. JERSEY CITY, N.J., Nov. 23, 2021 (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 peer-reviewed publication of results from its Phase 3 VANISH-306 study in the International Journal of Obstetrics and Gynaecology (BJOG). Results from the VANISH-306 study show that treatment with oral ibrexafungerp achieved superiority over placebo with a high degree of statistical significance on key study endpoints and was generally safe and well-tolerated. The VANISH development program’s two pivotal Phase 3 superiority studies, VANISH-303 and VANISH-306, supported the U.S. Food and Drug Administration’s (FDA) June 2021 approval of BREXAFEMME® (ibrexafungerp tablets) as a treatment for vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Please see prescribing information here. “Ibrexafungerp is a first-in-class, one-day oral therapy that blocks glucan synthase, an enzyme critical for the maintenance of the fungal cell wall, and has shown in vitro fungicidal activity against multiple different Candida species strains, including those that are echinocandin and azole resistant,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “We believe the publication of findings from our VANISH-306 study will provide clinicians with valuable knowledge regarding the efficacy and safety of this groundbreaking treatment as a potent therapeutic option for possibly millions of women across the country.” VANISH-306 was a global, multi-center, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of oral ibrexafungerp vs. placebo in women over the age of 12 with VVC. Ibrexafungerp demonstrated statistical superiority over placebo...