A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis

Inclusion Criteria:

- Are females at least 18 years of age in good general health who are not menopausal.

- Have a clinical diagnosis of bacterial vaginosis, defined as having all of the
following criteria:

- Off-white (milky or gray), thin, homogeneous vaginal discharge

- Vaginal pH ≥ 4.7

- Presence of clue cells of ≥ 20% of the total epithelial cells on microscopic
examination of the vaginal saline wet mount

- A positive 10% KOH Whiff test.

- Have a Gram stain slide Nugent score ≥ 4 at the Baseline visit (Day 1)

Exclusion Criteria:

- Are pregnant, lactating, or planning to become pregnant during the study.

- Are suspected clinically (or confirmed diagnostically) of having alternative causes of
vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis,
Neisseria gonorrhoeae or Herpes simplex.

- Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14
days prior to the Baseline visit (Day 1).