Pooled analysis of two phase III studies of ibrexafungerp in vulvovaginal candidiasis published in the Journal of Women’s Health

VANISH-303 and VANISH-306 were Phase III 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. 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 < 0.0001), Clinical improvement (VSS score less than 1) (68.4% [257/376] vs 45.1% [82/182]; p < 0.0001), 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 < 0.0001), Mycological cure (negative culture for Candida species) (54.0% [203/376] vs 24.2% [44/182]; p < 0.0001), Patients receiving ibrexafungerp who had severe VVC (VSS score at least 7) (94.1% [354/376]) experienced a clinical cure rate (56.2%) similar to the overall population (56.9%), and clinical cure rates remained unchanged with increasing VSS severity score. Ibrexafungerp was well-tolerated in the pooled analysis.

Adverse events were primarily gastrointestinal in nature and mild in severity.

See: "Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306" Oluwatosin Goje et al. Journal of Womens Health, Published Online:17 Oct 2022 https://doi.org/10.1089/jwh.2022.0132