Bacterial vaginosis (BV) is one of the most common gynecological conditions in women, with high recurrence rates that often require repeated antibiotic treatment.
This cycle increases the risk of antibiotic resistance and can lead to chronic, difficult-to-treat disease.
BV has also been linked to serious gynecological and reproductive complications, including infertility, adverse pregnancy outcomes, and increased cancer risk.
LABTHERA-001 is a microbiome-based therapeutic that exhibits direct antimicrobial activity against Gardnerella vaginalis (GV),
the primary pathogen associated with BV, and inhibits GV-induced biofilm formation.
In preclinical animal models of GV-induced dysbiosis, LABTHERA-001 significantly reduced GV pathogenic activity and restored healthy vaginal microbiome balance.
LABTHERA-001 demonstrated favorable safety and tolerability in a global Phase 1 clinical trial in Australia and is currently advancing through a Phase 2a clinical study.
As the only domestically developed microbiome-based therapeutic targeting female reproductive health, LABTHERA-001 aims to provide a safe,
disease-modifying treatment for BV by restoring and maintaining a healthy vaginal microbiome.