China-based Suzhou OSAI Biopharma Inc., a specialist in live biotherapeutic products (LBPs), has announced that its vaginal L. crispatus live bacteria capsule (Lc262-1) has achieved both primary and secondary endpoints in a Phase III study. The multicenter, randomized, double-blind, placebo-controlled trial involved 320 patients with bacterial vaginosis (BV). Following a seven-day course of oral metronidazole and vaginal LBP/placebo combination therapy, patients were monitored for three months. The treatment group showed statistically superior outcomes to the placebo group on the primary and secondary endpoints, with no significant difference in adverse events between the two groups.
The first-in-class Lc262-1 is engineered to restore healthy vaginal microbiota using L. crispatus, aiming to prevent and reduce the recurrence of vaginal infections. OSAI is now contemplating the ongoing development of Lc262-1, with plans to file a Biologics License Application (BLA) with the National Medical Products Administration (NMPA) in the near future.- Flcube.com
