Freya Biosciences Announces Positive Topline Clinical Trial Results for FB101 in Women with Asymptomatic Vaginal Dysbiosis

Freya Biosciences, a trans-Atlantic biotech company specializing in women’s health, announces positive topline results from its first Phase 1 clinical study of its lead asset FB101, an investigational vaginal microbial immunotherapeutic. These data allow the company to expand the clinical activities with FB101 to women seeking infertility treatment and undergoing in vitro fertilization (IVF).

The study, conducted in Europe, was a randomized, double-blind, placebo-controlled trial, evaluated the change in vaginal microbiome after vaginal administration of FB101 on three consecutive days in women with asymptomatic vaginal tract dysbiosis (NCT05114031). Results demonstrated dysbiosis resolution by a rapid switch from a dysbiotic to a Lactobacillus-dominated vaginal microbiome after administration of FB101, that was sustained for over 8 weeks. Furthermore, this trial showed that engraftment of the FB101 Lactobacilli species was established in half of the women (as determined by strain-level engraftment analysis). A change in inflammatory markers was also found. Freya intends to study FB101 for improving fertility outcomes and enhancing the success rates of IVF. Initial results will be shared by Johan van Hylckama Vlieg, Chief Scientific Officer of Freya Biosciences at the Microbiome Movement Summit in Boston later this month.

Asymptomatic vaginal dysbiosis is a common finding in women undergoing IVF procedures and has detrimental implications on treatment success.

“Data from a cohort study conducted in collaboration between Freya and a major U.S. clinic, Boston IVF, support the concept of lower pregnancy rates in women with a dysbiotic inflammatory vaginal microbiome compared to women without this condition when undergoing IVF,”

“We look forward to advancing the clinical development program with FB101, which has the potential of becoming the first targeted therapy for the IVF population with vaginal dysbiosis.”

said Joan-Carles Arce, Chief Medical Officer of Freya.

“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,”

said Colleen Acosta, CEO of Freya Biosciences.

“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.”

About Freya Biosciences

Freya is a biotech company based in Copenhagen, Denmark, dedicated to advancing women’s reproductive health. With a focus on reproductive microbial immunotherapy interventions, Freya aims to improve fertility outcomes and empower women with innovative solutions. For more information, please visit or visit us on LinkedIn.

NCT05114031: “FB101 Intervention in Asymptomatic Healthy Volunteers Who Have Undergone Vaginal Microbiome Screening – a Randomised, Double-blind, Placebo-controlled Study”.