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SCYNEXIS Presents Data at 2021 ACOG Demonstrating the Positive Outcome and Sustained Response of Investigational Oral Ibrexafungerp (Brexafemme™) in Difficult-to-Treat Patients with Vaginal Yeast Infections
A single-day dose of oral ibrexafungerp demonstrates positive clinical outcomes in difficult-to-treat vulvovaginal candidiasis (VVC) patient populations:
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[{"type":"text","content":"A single-day dose of oral ibrexafungerp demonstrates positive clinical outcomes in difficult-to-treat vulvovaginal candidiasis (VVC) patient populations: those with non-albicans Candida VVC and/or severe VVCBrexafemme, the expected trade name for ibrexafungerp, an oral antifungal product candidate for the treatment of vaginal yeast infections, is under regulatory review by the FDA, with a PDUFA target action date set for June 1, 2021 JERSEY CITY, N.J., April 30, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, presented posters on two data sets from the Company’s Phase 3 VANISH Program demonstrating the therapeutic potential of ibrexafungerp (Brexafemme) as a treatment for vulvovaginal candidiasis (VVC), also known as vaginal yeast infection, at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting, taking place virtually from April 30 – May 2, 2021. Presentation highlights are as follows: Title:Phase 3 Oral Ibrexafungerp Study in Vulvovaginal Candidiasis (VANISH-303): Outcomes in Non-albicans Candida spp.Poster #:ID961398Authors:Dr. Nkechi Azie, Dr. David Angulo, Dr. Paul NyirjesySummary:A sub-analysis of the VANISH-303 study identified 19 patients in the ibrexafungerp arm (300 mg BID, one-day oral dose) with non-albicans Candida (NAC) VVC. The current treatment recommendation is 7-14 days of topical azoles; fluconazole is not recommended. Treatment with ibrexafungerp resulted in a 42.1% clinical cure rate, defined as complete resolution of all Vaginal Signs and Symptoms (VSS=0) at the Day-10 test-of-cure visit, and 52.6% symptom resolution at the Day-25 follow-up visit. This analysis shows that clinical outcomes for NAC VVC patients on ibrexafungerp are comparable to all patients in the study. Furthermore, the trend of more patients having positive clinical outcomes and sustained response with ibrexafungerp by Day 25 was observed in all patients and the NAC sub-population. Title:Efficacy and Safety of Oral Ibrexafungerp in the treatment of Vulvovaginal Candidiasis: A Phase 3 Study (VANISH-306)Poster #:ID957079Authors:Dr. Nkechi Azie, Dr. David Angulo, Dr. Ryan SobelSummary:The VANISH-306 study evaluated the safety and efficacy of oral ibrexafungerp as a treatment ...