Biotech start-up reports positive clinical trial results for vaginal dysbiosis therapy

The women’s health biotech start-up Freya Biosciences has announced positive results from a clinical study of its investigational vaginal microbial treatment.

A clinical-stage company, Freya aims to take an innovative approach to women’s health by using microbial immunotherapies to relieve the chronic inflammation underlying a range of reproductive system diseases afflicting women.

The Phase 1 clinical study, conducted in Europe, was a randomised, double-blind, placebo-controlled trial and evaluated the change in vaginal microbiome of its investigational vaginal microbial immunotherapeutic, FB101, in women with asymptomatic vaginal tract dysbiosis – a situation whereby the vaginal microbiota experiences a reduction in the predominant population of lactobacillus.

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 eight weeks.

Furthermore, the trial showed that engraftment of the FB101 lactobacilli species was established in half of the women. A change in inflammatory markers was also found.

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

Joan-Carles Arce, chief medical officer of Freya, said: “Data from a cohort study conducted in collaboration between Freya and a major US clinic, Boston IVF, supports 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.”

Colleen Acosta, CEO of Freya Biosciences, said: “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.”

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.

The data is hoped to allow the company to expand the clinical activities with its lead asset FB101 to help women seeking infertility treatment and undergoing IVF.