Zhendong Pharmaceutical publishes Phase IIb trial results for lactobacillus capsule
Zhendong Pharmaceutical published double blind Phase IIb clinical study results in the National Medical Journal of China evaluating its investigational lactobacillus capsule for bacterial vaginosis
Beijing, September 30, 2026 - Zhendong Pharmaceutical has disclosed Phase IIb trial results for its investigational Live Double Combined Lactobacillus Capsule, designed for intravaginal use to treat bacterial vaginosis (BV). The study, published in the National Medical Journal of China, evaluated the product in 66 patients, randomly assigned to either the investigational treatment or a placebo.
The primary endpoint, measured at 7 to 16 days post-treatment (D21-30), showed a clinical cure rate of 52.4% in the investigational group compared to 31.8% in the placebo group (P=0.117). Secondary endpoints revealed significant differences at D15-18: 57.1% versus 22.7% clinical cure rates (P=0.009) and 54.8% versus 27.3% bacteriological cure rates (P=0.036).
Exploratory analysis indicated a 54.8% vaginal colonization rate for the administered strains at D21-30, occurring in 81.8% of clinically cured patients versus 25% of those not cured (P=0.001). Additionally, the investigational product led to a 6.64% increase in relative vaginal Lactobacillus abundance compared to a negligible change (-0.04%) in the placebo group (P=0.001).
Side effects were comparable between groups, with 11.6% of the investigational group and 8.7% of the placebo group experiencing drug-related adverse events, with no statistically significant difference (P=1.000). No serious adverse events related to the investigational product were reported. These findings present clinical data for planning larger, confirmatory Phase III studies.
BV results from vaginal microbiota imbalance, often involving a depletion of Lactobacillus-dominant microbiota. Current antibacterial treatments may not effectively restore normal microbial balance, highlighting the need for alternative solutions like the investigational capsule containing Lactobacillus gasseri and Lacticaseibacillus rhamnosus, administered intravaginally twice daily for 14 days to restore balance through competitive colonization, lactic acid production, and hydrogen peroxide production.
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