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SYM-1219 · 1 trial · 1 indication
Clinical Cure is a composite endpoint determined by normalization of the vaginal discharge and a negative KOH "Whiff" test and Clue cells less than 20% of the total epithelial cells on microscopic examination of the vaginal wet mount. (Number of subjects with clinical cure at TOC/EOS)
| Arm | Type | Description |
|---|---|---|
| SYM-1219 Low Dose | EXPERIMENTAL | Administered orally |
| SYM-1219 High Dose | EXPERIMENTAL | Administered orally |
| Placebo | PLACEBO_COMPARATOR | Administered orally |
| Name | Type | Description |
|---|---|---|
| SYM-1219 | DRUG | Oral |
| Placebo | DRUG | Oral |
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 * Presen...
SYM-1219 is an investigational small molecule being developed for the treatment of bacterial vaginosis, a common vaginal infection. It is currently in Phase 2 clinical development and is not yet approved by the FDA.
The specific molecular target of SYM-1219 has not been disclosed. It is classified as a small molecule therapeutic intended to treat bacterial vaginosis, but its mechanism of action has not been publicly detailed.
SYM-1219 is being developed by cbdMD, Inc., a company publicly traded under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the drug's safety and efficacy for bacterial vaginosis.
SYM-1219 is in Phase 2 clinical development. A Phase 2 study has been completed, but the drug remains investigational and has not received FDA approval. Further clinical development would be required before any regulatory submission.
SYM-1219 has one completed Phase 2 clinical trial, identified as NCT02147899. This randomized, double-blind, placebo-controlled study enrolled 215 female participants aged 18 years and older in the United States to evaluate the drug for bacterial vaginosis.