Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)

Summary

This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.

Timeline

Start

2019-01-04

Primary completion

2019-08-21

Completion

2019-09-04

Outcome

Met primary endpoint

paper significantly higher rates of clinical cure (56.9% [214/376 patients] vs. 35.7% [65/182 patients]) PMID 36255448 ↗

release “VANISH-303 ibrexafungerp efficacy results confirm results observed in the Phase 2b DOVE study and achieve the superiority versus placebo required for regulatory approval.” scynexis.com ↗

release “Ibrexafungerp achieved highly statistically significant superiority over placebo (p≤0.001) for the primary endpoint” scynexis.com ↗

release “In the VANISH-303 study, ibrexafungerp achieved superiority over placebo with high statistical significance (p≤0.001) for the key endpoints required to support the New Drug Application” scynexis.com ↗

release “In the Phase 3 VANISH-303 study, ibrexafungerp demonstrated significantly higher rates of clinical cure and infection eradication versus placebo.” scynexis.com ↗

Publications

• Goje O, Sobel R, Nyirjesy P, Goldstein SR, Spitzer M, Faught B, Larson S, King T, Azie NE, Angulo D, Sobel JD. Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306. J Womens Health (Larchmt). 2023 Feb;32(2):178-186. doi: 10.1089/jwh.2022.0132. Epub 2022 Oct 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibrexafungerp	Small molecule	300 mg	Oral

Indications