SCYNEXIS's Oral SCY-078 Receives FDA QIDP and Fast Track Designations for the Treatment of VVC and Prevention of Recurrent VVC
"These designations from the
"We recently completed enrollment in the Phase 2b DOVE study, enrolling more than 180 women with moderate to severe acute VVC," said
The QIDP designation, provided under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act, allows
About Vulvovaginal Candidiasis (VVC)
VVC, commonly known as a "yeast infection," is usually caused by Candidaalbicans, and typical symptoms include pruritus, vaginal soreness, irritation and abnormal vaginal discharge. An estimated 75% of women worldwide will have at least one episode of VVC in their lifetime, and 40%-50% of them will experience two or more episodes. As many as 8% of the women with VVC suffer from recurrent disease, defined as experiencing at least four episodes within a 12-month period. Current treatments for VVC include topical antifungals and the use of prescription oral antifungals such as fluconazole, which has a therapeutic cure rate of 55% as reported in the label. There are no products currently approved for the treatment of recurrent VVC. Most VVC infections occur in women of childbearing potential, and FDA has advised caution in prescribing oral fluconazole for the treatment of VVC during pregnancy.
SCY-078 is an investigational antifungal agent that is a semi-synthetic derivative of the natural product enfumafungin. SCY-078 is the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having IV and oral formulations. SCY-078 is currently in development for the treatment of fungal infections caused primarily by Candida (including C.auris) and Aspergillus species. It has demonstrated broad spectrum of anti-fungal activity, in vitro and in vivo, against multi-drug resistant pathogens, including azole- and echinocandin-resistant strains. The
Forward Looking Statement
Statements contained in this press release regarding expected future events or results, including but not limited to the Company's plans regarding clinical developments, timing of data review for the DOVE trial and possible initiation of a Phase 3 registration program in VVC, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS's ability to successfully develop and obtain FDA approval for SCY-078; the expected costs of studies and when they might begin or be concluded; and SCYNEXIS's reliance on third parties to conduct SCYNEXIS's clinical studies. These and other risks are described more fully in SCYNEXIS's filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K under the caption "Risk Factors" and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
MacDougall Biomedical Communications
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