An Active-Controlled, Dose-Finding Study of SCY-078 vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis

This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled,
dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis.
Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose
regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole)
for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site
visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).

Key Inclusion Criteria:

1. Subject is a female of at least 18 years of age

2. Subject has a diagnosis of symptomatic AVVC at baseline including a positive
microscopic examination with 10% KOH in a vaginal sample revealing yeast forms
(hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

Key Exclusion Criteria:

1. Subject has any vaginal condition other than AVVC that may interfere with the
diagnosis or evaluation of response to therapy, such as suspected or confirmed
concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)

2. Need for systemic and/or topical (vaginal) antifungal treatment, including
prescription or over-the-counter products during the study and treatment for VVC 28
days prior to randomization

3. Subject is actively menstruating at the time of the Baseline visit.

4. Subject has uncontrolled diabetes mellitus.

5. Subject has a vaginal sample with pH >4.5.

6. Subject has a history of or an active cervical/vaginal cancer.