The slide and audio webcast can be accessed by visiting the Investors section of the Company’s website at http://ir.scynexis.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website for 30 days.
About the VANISH Program
The VANISH program was designed following the 2016 “Vulvovaginal Candidiasis: Developing Drugs for Treatment, Guidance for Industry” by the FDA. The program is comprised of two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies designed to demonstrate superiority of oral ibrexafungerp versus placebo. For each study, patients with an acute episode of VVC with a signs and symptoms (S&S) score of four or greater on a scale of zero (no S&S) to 18 (maximum severity) are randomized to ibrexafungerp (two doses of 300mg 12 hours apart for one day) or placebo in a 2:1 ratio. Similar to the design of the Phase 2b DOVE study, primary efficacy analyses were conducted in themodified-intent-to-treat (mITT) population, comprised of patients with culture confirmedCandida spp. infection at baseline who received at least one dose of study treatment. The primary endpoint of each trial is clinical cure rate, defined as the complete resolution of all signs and symptoms (S&S) at theTest-of-Cure (TOC) visit (Day 10). Secondary endpoints include mycological eradication at TOC and complete symptom resolution at thefollow-up (FU) visit (Day 25). The VANISH-303 study was conducted in U.S. centers and the VANISH-306 study enrolled patients from sites in the U.S. and Europe. The Company plans to submit a New Drug Application (NDA) to the U.S. Food Drug Administration (FDA) for the treatment of VVC in the second half of 2020 based on the consistently positive results from the VANISH trials.
About Vulvovaginal Candidiasis (VVC)
VVC, commonly known as a vaginal yeast infection due toCandida, is the second most common cause of vaginitis. Although these infections are frequently caused byCandida albicans,fluconazole-resistantCandida strains, such asCandida glabrata, have been reported to become increasingly more common. VVC can be associated with substantial morbidity, including significant genital discomfort, reduced sexual pleasure, psychological distress and loss of productivity. Typical VVC symptoms include pruritus, vaginal soreness, irritation, excoriation of vaginal mucosa and abnormal vaginal discharge. An estimated70-75% of women worldwide will have at least one episode of VVC in their lifetime, and40-50% of them will experience two or more episodes. Approximately6-8% of women with VVC suffer from recurrent disease, defined as experiencing at least three episodes within a12-month period.
Current treatments for VVC include several topical azole antifungals (clotrimazole, miconazole, and others) and fluconazole, the only orally-administered antifungal currently approved for the treatment of VVC in the U.S. Fluconazole reported a 55% therapeutic cure rate in its label, which now also includes warnings of potential for fetal harm, illustrating the need for new oral alternatives. The needs of women withmoderate-to-severe VVC, recurrent VVC, VVC caused byfluconazole-resistantCandida spp. or VVC during child-bearing age are not fully addressed by oral fluconazole or topical products. In addition, there are no oral alternatives for VVC patients who do not respond to or do not tolerate fluconazole, and there are noFDA-approved products for the prevention of recurrent VVC.
About Ibrexafungerp
Ibrexafungerp [pronouncedeye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, the ‘fungerps’. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and IV formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily byCandida (includingC. auris) andAspergillus species. It has demonstrated broad spectrum antifungal activity,in vitro andin vivo, against
