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Pooled Data from the Pivotal Phase 3 VANISH Program Published in the Journal of Women’s Health Demonstrate Significant Efficacy of Ibrexafungerp Over Placebo for Treatment of Vaginal Yeast Infection
Clinical cure rates, in the pooled analysis, were statistically significantly greater for ibrexafungerp when compared with placebo (p In the pooled analysis,
About this update from Scynexis, Inc.
[{"type":"text","content":"Clinical cure rates, in the pooled analysis, were statistically significantly greater for ibrexafungerp when compared with placebo (p In the pooled analysis, patients receiving ibrexafungerp experienced significantly higher rates of clinical improvement, complete symptom resolution, and mycological cure compared to placebo (all p Ibrexafungerp demonstrated consistent efficacy in important patient sub-populations, characterized by race, body mass index, symptom severity, and Candida species infection. JERSEY CITY, N.J., Nov. 03, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced the peer-reviewed publication of positive results from a pooled analysis of two Phase 3 studies (VANISH-303 and VANISH-306) in the Journal of Women’s Health. “We are proud to have the pooled analysis from our Phase 3 VANISH program published in this important peer-reviewed journal,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS “The publication of these pooled data yield the largest placebo-controlled analysis in the treatment of acute VVC, to our knowledge. We believe these data provide clinicians with valuable insights regarding the safety and consistent efficacy of ibrexafungerp as a potent potential treatment option for a broad spectrum of patients in need.” VANISH-303 and VANISH-306 were Phase 3 randomized, multi-center, double-blind, placebo-controlled studies that evaluated the efficacy and safety of oral ibrexafungerp compared to placebo for the treatment of acute VVC in females over the age of 12. Key publication highlights: In the pooled analysis, ibrexafungerp demonstrated statistical superiority over placebo in all efficacy endpoints.Patients receiving ibrexafungerp experienced significantly higher rates at the test-of-cure visit compared to placebo in: Clinical cure (vulvovaginal signs and symptoms (VSS) score = 0) (56.9% [214/376] vs 35.7% [65/182]; p Clinical improvement (VSS score ≤1) (68.4% [257/376] vs 45.1% [82/182]; p Complete symptom resolution at the follow-up visit (symptom score = 0 without having received rescue antifungal treatment regardless of having achieved a clinical cure at the test-of-cure visit) (66.8% [251/376] vs 48.4% [88/182]; p Mycological cure (neg...