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.
For more information call (201) 884-5485 or visit Scynexis.com.