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SCYNEXIS Announces Two Oral Presentations on Pooled Data from the BREXAFEMME (Ibrexafungerp tablets) Phase 3 VANISH Program Demonstrating Consistent Efficacy in the Treatment for Vaginal Yeast Infections at the IDSOG 2021 Virtual Annual Meeting
The pooled data from two Phase 3 studies (VANISH-303 and VANISH-306) of one-day oral ibrexafungerp reflect a population that overwhelmingly had severe yeast
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[{"type":"text","content":"The pooled data from two Phase 3 studies (VANISH-303 and VANISH-306) of one-day oral ibrexafungerp reflect a population that overwhelmingly had severe yeast infections, a condition typically treated with multiple doses of oral fluconazoleIbrexafungerp demonstrated consistent efficacy in important patient sub-populations, characterized by age, race/ethnicity, body mass index and pathogen types JERSEY CITY, N.J., July 29, 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 two oral presentations of oral ibrexafungerp from its Phase 3 VANISH Program at the Infectious Diseases Society for Obstetrics & Gynecology (IDSOG) 2021 Virtual Annual Meeting, held on July 29 and July 30, 2021. The data presented demonstrate oral ibrexafungerp’s safety and efficacy as a treatment for vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. “The data from our Phase 3 VANISH program demonstrated strong efficacy and a favorable tolerability profile in women with vaginal yeast infections and supported the recent FDA approval of BREXAFEMME®, which represents the first approved drug in a novel antifungal class in more than 20 years, offering the first and only oral non-azole treatment option for VVC patients,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “We believe that we can continue to build on this momentum in this category with our ongoing Phase 3 CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect to report topline data in the first half of 2022.” Selected Important Safety Information Most common adverse reactions observed in clinical trials (incidence ≥2%) were diarrhea, nausea, abdominal pain, dizziness, and vomiting See below for complete Important Safety Information Oral presentation details: TitleEfficacy and Safety of Oral Ibrexafungerp in Subjects with Vulvovaginal Candidiasis: Pooled Data from Two Phase 3, Randomized, Blinded, Studies vs. Placebo (VANISH-303 and VANISH-306) Abstract #2PresenterJack D. Sobel, MDSessionScientific Session 1HighlightsThe Phase 3 VANISH-303 and VANISH-306 trials evaluated the safety and efficacy of oral ibrexafungerp as a treatment for patients with VVC. A pooled analysis of 37...