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

Symbiomix Therapeutics

Status and phase: Completed; Phase 2

Conditions: Bacterial Vaginosis

Treatments: Drug: Placebo; Drug: SYM-1219

Study type: Interventional

Funder types: Industry

Identifiers

NCT02147899

SYM-1219-201

Details and patient eligibility

About

The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.

Full description

:This was a Phase 2, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectivenessand safety of SYM-1219 in women with bacterial vaginosis. Patients determined to be eligible for the study were randomized to one of the following treatments: SYM-1219 1 gram orallyas a single dose;SYM-1219 2 grams orally as a single dose;or matching placebo. Patients determined to be eligible based on the clinical assessments at the Baseline visit (Day 1) were randomized in a 1:1:1 ratio and received a singledose of the assigned study treatment on Day 1 under fasted conditions (i.e., no food 2 hours prior to or 1 hour after dosing). The centralized randomization was stratified by the number of reported episodes of BV in the past 12 months (including the current episode): 3 or fewer episodes versus 4 or more episodes. Patients were asked to complete a daily telephone questionnaire on Days1to7 and at the Test of Cure (TOC)/End of Study (EOS)visit. Patients were also contacted by telephone once on Day 8 to 10 to inquire about possible adverse events (AEs). A TOC visit was conducted between Day 21 and 30; or at EOSif the final visit was notconducted between Day 21and30

Enrollment: 215 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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215 participants in 3 patient groups, including a placebo group

SYM-1219 Low Dose

Experimental group

Description:

Administered orally

Treatment:

Drug: SYM-1219

SYM-1219 High Dose

Experimental group

Description:

Administered orally

Treatment:

Drug: SYM-1219

Placebo

Placebo Comparator group

Description:

Administered orally

Treatment:

Drug: Placebo