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SCYNEXIS Announces Positive Top-Line Results from its Second Pivotal Phase 3 Study (VANISH-306) of Oral Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis (Vaginal Yeast Infection)
Ibrexafungerp achieved highly statistically significant superiority over placebo for the primary and key secondary study endpointsIbrexafungerp was generally
About this update from Scynexis, Inc.
[{"type":"text","content":"Ibrexafungerp achieved highly statistically significant superiority over placebo for the primary and key secondary study endpointsIbrexafungerp was generally safe and well-toleratedPositive results consistent with previously reported VANISH-303 study support anticipated NDA submission for the treatment of vulvovaginal candidiasis (VVC) in the second half of 2020Enrollment is ongoing in the CANDLE Phase 3 study of oral ibrexafungerp for the prevention of recurrent VVC, with supplemental NDA submission planned for the second half of 2021Conference call to be held April 21st, 2020 at 8:30 a.m. ET JERSEY CITY, N.J., April 21, 2020 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced positive top-line results for its Phase 3 VANISH-306 study investigating the safety and efficacy of oral ibrexafungerp, a novel broad-spectrum antifungal, as a treatment for women with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. With these results, ibrexafungerp has now achieved superiority over placebo with a high degree of statistical significance on key study endpoints required for regulatory approval of the VVC indication in both VANISH pivotal trials, clearing the way for the NDA submission for the treatment of VVC in the second half of 2020.\n “We are thrilled with the results from VANISH-306, which are consistent with the previously reported VANISH-303 study findings in supporting the efficacy and safety of oral ibrexafungerp as a novel treatment for women with vaginal yeast infections,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “Both VANISH Phase 3 studies also confirmed ibrexafungerp’s sustained clinical effect at the Day-25 follow-up visit, consistent with findings from the Phase 2b DOVE study. In parallel, we continue to advance our CANDLE Phase 3 study testing oral ibrexafungerp for the prevention of recurrent vaginal yeast infections, for which there are no approved therapies, and expect top-line data in this indication in the second half of 2021.” Marco Taglietti, M.D., Chief Executive Officer of SCYNEXIS added, “This marks the successful completion of our VANISH Phase 3 program, with planned NDA submission to the FDA later this year. If approved, ibrexaf...