Scynexis biotechnology company on Thursday 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).
Scynexis said that ibrexafungerp achieved superiority over placebo at a highly statistically significant level for the primary endpoint and key study endpoints required for regulatory approval of the VVC indication.
According to Scynexis, these top-line results come earlier than originally anticipated due to faster-than-expected enrollment in VANISH-303 and support the its 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.
Dr. Marco Taglietti, President and Chief Executive Officer of Scynexis, said that these results confirm the clinical benefits and favorable tolerability profile observed in the company’s Phase 2b DOVE study, strengthening its confidence in ibrexafungerp’s future regulatory and commercial success.
He said 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.”
Dr. Taglietti said he is confident in the outcome of the company’s ongoing second pivotal Phase 3 study (VANISH-306).
The company said that the VANISH-303 study was designed following the 2016 “Vulvovaginal Candidiasis: Developing Drugs for Treatment, Guidance for Industry” by the FDA. The study was conducted at 28 centers in the U.S. and enrolled 376 patients randomized to oral ibrexafungerp (single-day 600mg dose regimen consisting of two doses of 300mg administered 12 hours apart) or matching placebo in a 2:1 ratio. To be eligible for this study, patients needed to present with an acute episode of VVC with a signs and symptoms (S&S) score of four or greater on a scale of zero (no S&S) to 18 (maximum severity). Primary efficacy analyses were conducted in the modified-intent-to-treat (mITT) population, comprised of patients with culture confirmed Candida spp. infection at baseline who received at least one dose of study treatment. The characteristics for both groups were evenly balanced at baseline, including the severity of the vaginal infection.