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SCYNEXIS Completes Last-Patient/Last-Visit Ahead of Schedule in the First Phase 3 Study (VANISH 303) of Oral Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis (VVC)
JERSEY CITY, N.J., Sept. 18, 2019 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for
About this update from Scynexis, Inc.
[{"type":"text","content":" JERSEY CITY, N.J., Sept. 18, 2019 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced completion of the last-patient/last-visit in its Phase 3 VANISH 303 study, and that it expects to release top-line data earlier than previously reported. Ibrexafungerp (formerly SCY-078) is the first representative of a novel family of antifungal compounds referred to as triterpenoids. SCYNEXIS is developing ibrexafungerp for the treatment of both serious outpatient fungal infections as well as hospital-based, life-threatening fungal infections. \n\"I am proud to report that our VVC clinical studies are progressing ahead of schedule, showing the execution strength of our team. The last patient has completed her last visit in our first Phase 3 study, VANISH 303, and we now expect top-line data by the end of this year,\" said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. \"Additionally, enrollment is also advancing ahead of expectations in our second Phase 3 study, VANISH 306, with data now anticipated in early second quarter of 2020.\" \nDr. Taglietti continued, \"The rapid enrollment observed in our VVC studies reaffirms our belief that a large number of patients and their treating physicians are not satisfied with existing therapies and are looking for alternatives. It provides validation of our VVC commercial expectations for ibrexafungerp, as a non-azole, fungicidal, oral agent. We remain on-track for a New Drug Application (NDA) submission in the second half of 2020.\"\nIbrexafungerp Update:\nSignificant progress made in the Phase 3 VANISH program evaluating the safety and efficacy of oral ibrexafungerp (300mg BID for one day) for the treatment of VVC\nThe VANISH program is comprised of two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies: The VANISH 303 study was conducted in U.S. centers and enrolled 376 patients. The last patient has now completed her final visit, ahead of schedule. Top-line data from the study is now expected by year-end 2019. More information about this study can be found at: https://clinicaltrials.gov/ct2/show/NCT03734991. The VANISH 306 study is expected to enroll approximately 360 patients from sites in the U.S. and Europe; the enroll...