Freya Biosciences, a trans-Atlantic biotech company specializing in women's health, has announced positive topline results from its first Phase 1 clinical study of FB101. This investigational vaginal microbial immunotherapeutic has shown promising results in treating asymptomatic vaginal dysbiosis. The study was conducted in Europe and evaluated the change in vaginal microbiome after three consecutive days of vaginal administration of FB101. The results demonstrated a rapid switch from a dysbiotic to a Lactobacillus-dominated vaginal microbiome, which was sustained for over 8 weeks. Additionally, engraftment of the FB101 Lactobacilli species was established in half of the women. Freya intends to further study FB101 for improving fertility outcomes and enhancing the success rates of IVF.
Asymptomatic vaginal dysbiosis is common among women undergoing IVF procedures and can negatively impact treatment success. Collaborative research between Freya and Boston IVF clinic found that women with a dysbiotic inflammatory vaginal microbiome had lower pregnancy rates compared to those without this condition during IVF. Therefore, FB101 has the potential to become the first targeted therapy for the IV