The FDA has granted both qualified infectious disease product (QIDP) and fast-track designations for the oral formulation of SCY-078 (SCYNEXIS, Inc.), a novel antifungal agent, for the treatment of vulvovaginal candidiasis (VVC) and for the prevention of recurrent VVC. In addition, the company announced it has completed enrollment in the phase 2b, dose-finding study of oral SCY-078 for the treatment of VVC (the DOVE study), with release of top-line data expected by July 2018. A phase 3 registration program is anticipated to start in the fourth quarter of 2018.
The QIDP designation, provided under the 2012 Generating Antibiotic Incentives Now Act, allows SCYNEXIS to have priority review, eligibility for fast-track status, and an additional five years of market exclusivity in the U.S. for SCY-078.
VVC, commonly known as a yeast infection, is usually caused by Candida albicans, 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% to 50% of them will experience two or more episodes. As many as 8% of 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 the 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 semisynthetic derivative of the natural product enfumafungin. SCY-078 is the first representative of a novel class of structurally distinct glucan synthase inhibitors called triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having intravenous 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 a broad spectrum of antifungal activity in vitro and in vivo against multidrug resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted QIPD and fast-track designations for the formulations of SCY-078 for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA), and VVC, and has granted orphan drug designation for the IC and IA indications.
Source: SCYNEXIS, Inc.; May 1, 2018.