Drug development company SCYNEXIS, Inc. (Nasdaq: SCYX) today announced that the U.S. Food and Drug Administration (FDA) has granted both Fast Track and Qualified Infectious Disease Product (QIDP) designations for the intravenous (IV) formulation of SCY-078, SCYNEXIS’ novel antifungal product, for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis. SCYNEXIS is currently conducting a Phase 1 study of the IV formulation of SCY-078 to evaluate the safety, tolerability and pharmacokinetics of single-rising doses. The FDA granted QIDP and Fast Track designations for the oral formulation of SCY-078 for both the treatment of invasive candidiasis and invasive aspergillosis in 2014. The oral formulation is currently in Phase 2 development for both invasive candidiasis and vulvovaginal candidiasis.
“In the 2016 revision of its clinical guidelines for the management of candidiasis, the Infectious Diseases Society of America (IDSA) strongly recommends the use of echinocandins as initial therapy for invasive candidiasis. These recommendations are based on better overall outcomes observed with echinocandins — the only glucan synthase inhibitors currently available — when compared to azoles,” said Dr. Peter Pappas, Principal Investigator of the Mycoses Study Group and Professor of Infectious Diseases at the University of Alabama School of Medicine. “SCY-078, a glucan synthase inhibitor, holds significant potential to become a first-line treatment alternative for this life-threatening condition. We view the FDA’s granting of Fast Track and QIDP designations as validation of the potential value of SCY-078 as a promising new antifungal agent.”
“SCY-078, the first representative of a novel class of glucan synthase inhibitors, goes beyond the two main classes of antifungal agents currently used for fungal infections by combining the best attributes of azoles and echinocandins,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “SCY-078 allows for both oral and IV administrations, like an azole, and is designed to block an established target in clinically relevant infectious fungi such as Candida and Aspergillus, like an echinocandin, including multi-drug resistant strains. Holding QIDP and Fast Track designations for both formulations further fosters our plans for expedited development of this innovative product in multiple indications addressing well-recognized medical and market needs.”
The FDA’s Fast Track Drug Development Program is a process designed to facilitate the development and expeditious review of drugs to treat serious conditions and fill unmet medical needs. This designation allows for companies to interact with the FDA review team frequently to discuss critical development issues such as study design, required safety data necessary to support approval, and structure and content of a New Drug Application (NDA). Additionally, should the FDA determine that a Fast Track product may be effective after their preliminary evaluation of clinical data submitted by a sponsor, the FDA may also consider reviewing portions of a marketing application before the sponsor submits the complete application, known as a “rolling” NDA.
The QIDP designation, provided under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) 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.
Date of article/Start date of trial: 28 January 2016