New Jersey based biotechnology company, SCYNEXIS, Inc. announced this week that the U.S. Food and Drug Administration(FDA) has granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations for the oral formulation of SCY-078, SCYNEXIS’s novel oral and intravenous antifungal agent, for the treatment of vulvovaginal candidiasis (VVC) and for the prevention of recurrent VVC.
Additionally, SCYNEXIS announced it has completed enrollment 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.
“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,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “We believe SCY-078 will provide a beneficial treatment option for healthcare 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.”
“We recently completed enrollment in the Phase 2b DOVE study, enrolling more than 180 women with moderate to severe acute VVC,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “This study is designed to assess the efficacy, safety, tolerability and pharmacokinetics of five different regimens of oral SCY-078 to identify the optimal dose to be tested in a Phase 3 registration program, which is anticipated to start in the fourth quarter of 2018.”
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.
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. The Fast Track designation allows for more frequent interaction with the FDAreview team to discuss critical development issues such as study design, required safety data to support approval, and the 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.
VVC, commonly known as a “yeast infection,” is usually caused by Candidaalbicans, and typical symptoms include pruritus, vaginal soreness, irritation and abnormal vaginal discharge. An estimated 75% of women worldwide will have at least one episode of VVC in their lifetime, and 40%-50% of them will experience two or more episodes. As many as 8% of the women with VVC suffer from recurrent disease, defined as experiencing at least four episodes within a 12-month period. Current treatments for VVC include topical antifungals and the use of prescription oral antifungals such as fluconazole, which has a therapeutic cure rate of 55% as reported in the label. There are no products currently approved for the treatment of recurrent VVC. Most VVC infections occur in women of childbearing potential, and FDA has advised caution in prescribing oral fluconazole for the treatment of VVC during pregnancy.