Posted by Michael Wonder on 01 May 2018
Scynexis' oral SCY-078 receives FDA QIDP and fast track designations for the treatment of VVC and prevention of recurrent VVC
1 May 2018 - Enrollment completed in Phase 2b DOVE study in VVC; on-track for top-line data by July 2018.
Scynexis today announced that the U.S. FDA has granted both qualified infectious disease product and fast track designations for the oral formulation of SCY-078, Scynexis' novel oral and intravenous anti-fungal agent, for the treatment of vulvovaginal candidiasis (VVC) and for the prevention of recurrent VVC.
Additionally, Scynexis today announced it has completed enrolment 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.
