Benzinga | Nov 23, 2021 08:32AM EST

SCYNEXIS Says Pivotal Phase 3 VANISH-306 Trial Results Published In International Journal Of Obstetrics And Gynaecology Demonstrate Statistical Superiority Of BREXAFEMME Over Placebo For Vaginal Yeast Infection

SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the peer-reviewed publication of results from its Phase 3 VANISH-306 study in the International Journal of Obstetrics and Gynaecology (BJOG). Results from the VANISH-306 study show that treatment with oral ibrexafungerp achieved superiority over placebo with a high degree of statistical significance on key study endpoints and was generally safe and well-tolerated.

The VANISH development program's two pivotal Phase 3 superiority studies, VANISH-303 and VANISH-306, supported the U.S. Food and Drug Administration's (FDA) June 2021 approval of BREXAFEMME(r) (ibrexafungerp tablets) as a treatment for vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Please see prescribing information here.

"Ibrexafungerp is a first-in-class, one-day oral therapy that blocks glucan synthase, an enzyme critical for the maintenance of the fungal cell wall, and has shown in vitro fungicidal activity against multiple different Candida species strains, including those that are echinocandin and azole resistant," said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. "We believe the publication of findings from our VANISH-306 study will provide clinicians with valuable knowledge regarding the efficacy and safety of this groundbreaking treatment as a potent therapeutic option for possibly millions of women across the country."

VANISH-306 was a global, multi-center, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of oral ibrexafungerp vs. placebo in women over the age of 12 with VVC. Ibrexafungerp demonstrated statistical superiority over placebo in the primary endpoint and all key secondary endpoints. At the test-of-cure (TOC) Day-10 visit, patients receiving ibrexafungerp had significantly higher rates of clinical cure vs. placebo (63.3% [119/188] vs. 44.0% [37/84]; P=0.007), which was defined as complete resolution of vulvovaginal signs and symptoms (VSS=0) without need for further antifungal treatment or topical drug therapy before or at the TOC visit. Day-10 results also showed significantly higher rates for ibrexafungerp vs. placebo in mycological eradication (58.5% [110/188] vs. 29.8% [25/84]; P<0.001), and clinical improvement (72.3% [136/188] vs. 54.8% [46/84]; P=0.01). Ibrexafungerp was generally well tolerated. Reported adverse events were primarily gastrointestinal and mild to moderate in severity.

In addition, at the Day-25 visit, symptom resolution was sustained and further increased with ibrexafungerp compared to placebo (73.9% vs. 52.4%; P=0.001). Significant results were also seen in patients with C. albicans at baseline, with complete symptom resolution (77.0% [127/165] of patients receiving ibrexafungerp compared to placebo (52.6% [40/76]; P<0.001).

The full VANISH-306 trial publication in BJOG can be found online here.