Freya Biosciences, a biotech company specializing in women’s health, has released positive topline results from the Phase 1 clinical trial of FB101, their vaginal microbial immunotherapeutic. The trial focused on addressing asymptomatic vaginal dysbiosis, a common condition in women undergoing infertility treatments. The findings show promise for improving fertility outcomes, particularly in in vitro fertilization (IVF) procedures.

Freya Biosciences, headquartered in Copenhagen, Denmark, is dedicated to advancing women’s reproductive health through research in reproductive microbial immunotherapy interventions.

The Phase 1 trial, conducted in Europe, employed a randomized, double-blind, placebo-controlled approach to evaluate the impact of FB101 on the vaginal microbiome of women with asymptomatic vaginal tract dysbiosis (NCT05114031). Participants received vaginal administration of FB101 over three consecutive days. The trial results indicate a positive shift from a dysbiotic to a Lactobacillus-dominated vaginal microbiome, which persisted for over 8 weeks, suggesting potential long-term efficacy.

In addition, strain-level analysis revealed successful engraftment of FB101 Lactobacilli species in 50% of the participants. Furthermore, inflammatory markers associated with dysbiosis showed a reduction, indicating the potential of FB101 as a targeted therapy for women with vaginal dysbiosis undergoing IVF.

Collaborative research between Freya Biosciences and Boston IVF, a renowned U.S. clinic, has provided further insights into the impact of dysbiotic inflammatory vaginal microbiomes on IVF success rates. Cohort study data suggest lower pregnancy rates in women with a dysbiotic vaginal microbiome compared to those without this condition during IVF. These findings emphasize the need to develop therapies like FB101 to address this challenge.

Johan van Hylckama Vlieg, Chief Scientific Officer of Freya Biosciences, is scheduled to present the initial trial results at the Microbiome Movement Summit in Boston. This presentation aims to highlight FB101’s potential in enhancing fertility outcomes and improving IVF success rates.

Colleen Acosta, CEO of Freya Biosciences comments: “We are very encouraged by the promising Phase 1 results of our lead candidate, FB101, and are incredibly proud of our team and clinical partners for enabling this milestone. The initial results additionally give strength to our platform and lay the groundwork for further pipeline programs with Freya’s immunotherapeutic candidates for other conditions within the women’s health area.”

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