First-in-Class Antifungal Fast-Tracked for Vulvovaginal Candidiasis

Vulvovaginal candidiasis
Vulvovaginal candidiasis
SCY-078 is an investigational antifungal agent that is a semi-synthetic derivative of the natural product enfumafungin.

Scynexis announced that the Food and Drug Administration (FDA) has granted Fast Track and Qualified Infectious Disease Product (QIDP) designations for the oral formulation of SCY-078 for the treatment of vulvovaginal candidiasis (VVC) and for the prevention of recurrent VVC. 

Currently, there is no approved therapy to treat recurrent VVC. SCY-078 is an investigational oral and intravenous (IV) antifungal agent that is a semi-synthetic derivative of enfumafungin. It is a first-in-class agent of structurally-distinct glucan synthase inhibitors called triterpenoids. 

In Phase 1 studies, SCY-078 was generally well-tolerated at clinically relevant doses. It has demonstrated a broad spectrum of antifungal activity in vitro  and in vivo against multi-drug resistant pathogens, including azole- and echinocandin-resistant strains. 

The most common adverse events following oral administration were mild or moderate gastrointestinal events; the most common adverse events following IV administration were local reactions at the injection site.  

Scynexis also announced that patient enrollment for a Phase 2b, dose-finding study of oral SCY-078 (DOVE study) in the treatment of VVC has been completed. This study is intended to assess the safety, efficacy, tolerability, and pharmacokinetics of 5 different regimens of oral SCY-078 to determine the optimal dose to be tested in a Phase 3 program; top-line data are expected by July 2018 and the Phase 3 program is anticipated to start in the 4th quarter. 

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This article originally appeared on MPR