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
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:
Dr. Marco Taglietti, President and Chief Executive Officer of SCYNEXIS added, “Last year, an estimated 9.5 million women in the U.S. received prescriptions for vaginal yeast infections, however, about 40% of them required multiple prescriptions, illustrating a growing need for new treatment options. We believe our oral, fungicidal, non-azole candidate, ibrexafungerp, if approved for the treatment of vaginal yeast infections, may provide a significant benefit for clinicians and patients not satisfied with existing azole-based therapies.”
Brexafemme, the expected trade name for ibrexafungerp, an oral antifungal product candidate for the treatment of vaginal yeast infections, is under regulatory review by the U.S. Food and Drug Administration (FDA) with a PDUFA target action date set for June 1, 2021. The New Drug Application submission to the FDA was supported by positive data from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306) in which oral ibrexafungerp demonstrated statistical superiority with a favorable tolerability profile.
All posters are live via the ACOG virtual meeting platform starting April 30th at 11 am ET. Register to attend via Link.
The posters will be made be available for 3 months and can be found on the SCYNEXIS website at: https://www.scynexis.com/news-media/events
About Brexafemme™ (ibrexafungerp)
About Vulvovaginal Candidiasis
Current treatments for VVC include several topical azole antifungals and oral fluconazole, which is the only orally administered antifungal currently approved for the treatment of VVC in the U.S. and which accounts for over 90% of the prescriptions written for this condition every year. Fluconazole reported a 55% therapeutic cure rate in its label, which now also includes warnings of potential fetal harm, illustrating the need for new oral alternatives. In addition, there are many women who often do not respond to or do not tolerate fluconazole, such as women with persistent (“chronic”) infections, recurrent infections (four or more recurrences in a 12-month period), Non-albicans / azole-resistant Candida strains (e.g., Candida glabrata), diabetic patients, especially with poorly controlled glycemia, and obese patients. These women could benefit from a non-azole, and preferably, oral treatment option.
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