SCYNEXIS Reports Positive Top-Line Results from First Phase 3 Registration Study of Oral Ibrexafungerp in Vulvovaginal Candidiasis (VANISH-303)

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[{"type":"text","content":"JERSEY CITY, N.J., Nov. 7, 2019 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced positive top-line results for its Phase 3 VANISH-303 study investigating the safety and efficacy of oral ibrexafungerp as a treatment for women with vulvovaginal candidiasis (VVC). Specifically, ibrexafungerp achieved superiority over placebo at a highly statistically significant level (p≤0.001) for the primary endpoint and key study endpoints required for regulatory approval of the VVC indication. These top-line results come earlier than originally anticipated due to faster-than-expected enrollment in VANISH-303 and support the Company's stated timeline to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the treatment of VVC in the second half of 2020.\n\"I am very excited about the positive top-line results of oral ibrexafungerp showing highly significant statistical superiority over placebo in our VANISH-303 Phase 3 registration study,\" said Dr. Marco Taglietti, President and Chief Executive Officer of SCYNEXIS. \"These results confirm the clinical benefits and favorable tolerability profile observed in our Phase 2b DOVE study, strengthening our confidence in ibrexafungerp's future regulatory and commercial success. Ibrexafungerp is the first molecule in an entirely new class of antifungals and possesses key attributes relevant to the VVC indication, including fungicidal activity against Candida. We believe that ibrexafungerp, as a novel, non-azole, oral therapy, can address large unmet medical needs for women with VVC who may not respond to fluconazole, the only oral option currently available, which is fungistatic against Candida and also has well-documented concerns around drug-drug interactions and embryo-fetal toxicity for women of childbearing age. I am particularly encouraged by the rapid enrollment seen in our VANISH program, which attests to patients' and physicians' desire for new and effective therapies.\"\nDr. Taglietti continued, \"Having achieved such a successful result in our first pivotal Phase 3 study, we are increasingly confident in the outcome of our ongoing second pivotal Phase 3 study (VANISH-306). I would like to thank the team here at SCYNEXIS, our study...

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