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 endpoints
Ibrexafungerp 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. ETJERSEY 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.“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, ibrexafungerp would be the first and only oral, non-azole treatment for vaginal yeast infections – a condition that affects three out of four women in their lifetime but has limited treatment options, with no new approved therapies in over 20 years. The positive results from our VANISH program give us confidence that ibrexafungerp has the potential to address vaginal yeast infections across a broad range of disease severity, and could be an ideal treatment option particularly for patients not currently satisfied with existing therapies.”VANISH-306 Efficacy Results:63.3 percent of ibrexafungerp-treated patients met the primary endpoint of clinical cure at the Day-10 test-of-cure (TOC) visit, defined as the complete resolution of all vaginal signs and symptoms (S&S) following a single-day 600mg dose regimen consisting of two doses of 300mg administered 12 hours apart.58.5 percent of ibrexafungerp-treated patients met the secondary endpoint of mycological eradication at TOC visit, defined as negative culture.72.3 percent of ibrexafungerp-treated patients were categorized as clinically improved at TOC visit, defined as having total signs and symptoms of 0 or 1.73.9 percent of ibrexafungerp-treated patients had complete symptom resolution at the Day-25 follow-up (FU) visit.
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