Scynexis's SCY-078 Receives FDA QIDP, Fast Track Designation for Vulvovaginal Candidiasis
The enrollment for the phase 2b DOVE study in VC is completed and the top-line data is expected by July 2018.
The US Food and Drug Administration (FDA) granted both qualified infectious disease product (QIDP) and fast track designations for the oral formulation of SCY-078 for the treatment of vulvovaginal candidiasis (VVC) and the prevention of recurrent VVC, announced Scynexis.
Additionally, Scynexis announced it has completed enrollment in the phase 2b, dose-finding study for treatment of VVC (the DOVE study), with top-line data to be released by July 2018.
The DOVE study, which enrolled more than 180 women with moderate to severe acute VVC, is designed to assess the efficacy, safety, tolerability and pharmacokinetics of 5 different regimens of the oral treatment in order to identify the optimal dose for the phase 3 registration program. The phase 3 program is anticipated to start in the fourth quarter of 2018.
“These designations from the FDA for the treatment of VVC and prevention of recurrent VVC highlight the significant unmet needs faced by women suffering from these widespread infections,” Marco Taglietti, MD, president, chief executive officer, Scynexis, said in a statement. “We believe SCY-078 will provide a beneficial treatment option for health care providers and women not satisfied with existing therapies. Moreover, we can now make use of the QIDP and fast track designations across all current SCY-078 development programs, including VVC, invasive candidiasis and invasive aspergillosis.”
Current treatments include topical antifungals and the use of prescription oral antifungals such as fluconazole, however, there are no products currently approved for the treatment of recurrent VVC.
The novel oral intravenous antifungal agent is a semi-synthetic derivative of the natural product enfumafungin and is the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids.
SCY-078 is currently in development for treatment of fungal infections caused by Candida (including C. auris) and Aspergillus species.
The FDA has granted QIPD and fast track designation for the formulations of SCY-078 for indications of invasive candidiasis, invasive aspergillosis and VVC, and additionally, has granted orphan drug designation for the invasive candidiasis and invasive aspergillosis indications.
The QIDP designation allows Scynexis to have priority review, eligibility for fast-track status and an additional 5 years of market exclusivity in the US.
